n−3 Fatty acid supplementation for the treatment of dry eye disease

Penny Asbell, G. Maguire, Maxwell Pistilli, Gui Shuang Ying, Loretta B. Szczotka-Flynn, David R. Hardten, Meng C. Lin, Roni M. Shtein, M. M. Hom, M. Quintana, A. Zermeno, R. Pendleton, D. McCluskey, D. Amador, I. Corona, V. Wechter, C. Childs, U. Do, M. Lerma, W. Li & 204 others Z. Young, T. Yuen, H. Dubiner, H. Ambrosia, M. Bowser, P. Chen, C. Fuller, K. New, T. V. Nguyen, E. Seville, D. Strait, C. Wang, S. Williams, R. Weber, J. Sutphin, M. Bishara, A. Bryan, A. Ertel, K. Green, G. Pantoja, A. Small, C. Williamson, J. Greiner, E. DiPronio, M. Lindsay, A. McPherson, P. Oliver, R. Wu, R. Dana, T. Abud, L. Adams, M. Arnofsky, J. Candlish, P. Chilakamarri, J. Ciolino, N. Crandall, A. Di Zazzo, M. Fernandes, M. Jafri, B. Johnson, A. Kheirkhah, S. Kiebdaj, A. Mullins, M. Nova, V. Satitpitakul, C. Shao, K. Suri, V. Tadla, S. Ujwala, J. Yin, M. Yu, C. Hood, M. Hussain, E. Manno, L. Rozek, K. Baker, A. Belsaas, E. Berg, A. Blakstad, K. DauSchmidt, L. Fallenstein, A. M. Fahmy, M. M. Fahmy, G. Georges, D. E. Harter, S. G. Hauswirth, M. Johnson, E. Meshalkin, R. Pelzer, J. Tisdale, J. C. Wick, J. Tauber, M. Hefter, S. Silverstein, C. Bentley, E. Dominguez, K. Kleinsasser, B. Barry, E. Kuklinski, A. Amir, N. Chen, M. Oydanich, V. Spahiu, A. Vo, M. Weinstein, T. Vaz, H. Hindman, R. Aleese, A. Czubinski, G. Gagarinas, P. McDowell, G. O'Gara, K. Steinmetz, V. Bunya, M. Bezzerides, D. Caggiano, S. Drossner, J. Dupont, M. Keiser, M. Massaro, S. Orlin, R. O'Sullivan, M. Christensen, H. Adkins, R. Brafford, C. Ervin, R. Grant, C. Newman, L. Shettle, D. Shettle, S. Cohen, D. Rodman, T. Caster, P. Gupta, S. Raghupathy, R. Sayegh, J. Shen, N. Drutz, L. Joyner, M. Mathis, M. Menghini, C. Robinson, D. Goldberg, L. Jenkins, B. Rodriguez, J. P. Jones, N. Thompson, B. Wolstan, M. Jones, A. Lemaster, J. Ransom-Chaney, W. Rudy, P. Hamrah, M. Commodore, C. Iyore, L. Lazarev, L. Mullen, N. Pondelis, C. Satsuma, S. Jain, P. Cowen, J. Hallak, C. Mun, R. Toh, I. Singh, P. Lightfield, E. Lowery, S. Ornelas, R. K. Sanka, B. Saunders, S. P. Mulqueeny, M. Pohlmeier, C. Aune, H. Gabriel, K. M. Walker, J. Newsome, R. Centers, M. Farkouh, S. Kim-Schulze, R. Chapkin, G. Greco, A. Simopoulos, I. Lashley, P. Dentone, N. Gadaria-Rathod, M. Massingale, N. Antonova, M. Brightwell-Arnold, J. Farrar, S. Harkins, J. Huang, K. McWilliams, E. Peskin, S. Ryan, H. Smolen, C. Whearry, Y. Yu, Y. Wei, Neeta Roy, S. Epstein, K. Rockwell, A. Moser, R. O. Jones, E. Daniel, E. R. Martin, C. P. Ostroff, E. Smith, P. A. Kadakia, M. Redford, S. Wisniewski, T. Brenna, W. G. Christen, J. F. Huang, C. S. McCarthy, S. T. Mayne, M. Palta, O. D. Schein, J. Chuang, M. Marchan, T. Hao, C. Heisler, C. Hu, C. Throop, V. Moolchandani

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

BACKGROUND Dry eye disease is a common chronic condition that is characterized by ocular discomfort and visual disturbances that decrease quality of life. Many clinicians recommend the use of supplements of n−3 fatty acids (often called omega-3 fatty acids) to relieve symptoms. METHODS In a multicenter, double-blind clinical trial, we randomly assigned patients with moderate-to-severe dry eye disease to receive a daily oral dose of 3000 mg of fish-derived n−3 eicosapentaenoic and docosahexaenoic acids (active supplement group) or an olive oil placebo (placebo group). The primary outcome was the mean change from baseline in the score on the Ocular Surface Disease Index (OSDI; scores range from 0 to 100, with higher scores indicating greater symptom severity), which was based on the mean of scores obtained at 6 and 12 months. Secondary outcomes included mean changes per eye in the conjunctival staining score (ranging from 0 to 6) and the corneal staining score (ranging from 0 to 15), with higher scores indicating more severe damage to the ocular surface, as well as mean changes in the tear break-up time (seconds between a blink and gaps in the tear film) and the result on Schirmer's test (length of wetting of paper strips placed on the lower eyelid), with lower values indicating more severe signs. RESULTS A total of 349 patients were assigned to the active supplement group and 186 to the placebo group; the primary analysis included 329 and 170 patients, respectively. The mean change in the OSDI score was not significantly different between the active supplement group and the placebo group (−13.9 points and −12.5 points, respectively; mean difference in change after imputation of missing data, −1.9 points; 95% confidence interval [CI], −5.0 to 1.1; P=0.21). This result was consistent across prespecified subgroups. There were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change, 0.0 points; 95% CI, −0.2 to 0.1), corneal staining score (0.1 point; 95% CI, −0.2 to 0.4), tear break-up time (0.2 seconds; 95% CI, −0.1 to 0.5), and result on Schirmer's test (0.0 mm; 95% CI, −0.8 to 0.9). At 12 months, the rate of adherence to treatment in the active supplement group was 85.2%, according to the level of n−3 fatty acids in red cells. Rates of adverse events were similar in the two trial groups. CONCLUSIONS Among patients with dry eye disease, those who were randomly assigned to receive supplements containing 3000 mg of n−3 fatty acids for 12 months did not have significantly better outcomes than those who were assigned to receive placebo. (Funded by the National Eye Institute, National Institutes of Health; DREAM ClinicalTrials.gov number, NCT02128763).

Original languageEnglish (US)
Pages (from-to)1681-1690
Number of pages10
JournalNew England Journal of Medicine
Volume378
Issue number18
DOIs
StatePublished - Jan 1 2018

Fingerprint

Eye Diseases
Omega-3 Fatty Acids
Placebos
Confidence Intervals
Tears
Staining and Labeling
lissamine rhodamine B
Therapeutics
National Eye Institute (U.S.)
Eicosapentaenoic Acid
Docosahexaenoic Acids
National Institutes of Health (U.S.)
Eyelids
Fishes
Quality of Life
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Asbell, P., Maguire, G., Pistilli, M., Ying, G. S., Szczotka-Flynn, L. B., Hardten, D. R., ... Moolchandani, V. (2018). n−3 Fatty acid supplementation for the treatment of dry eye disease. New England Journal of Medicine, 378(18), 1681-1690. https://doi.org/10.1056/NEJMoa1709691

n−3 Fatty acid supplementation for the treatment of dry eye disease. / Asbell, Penny; Maguire, G.; Pistilli, Maxwell; Ying, Gui Shuang; Szczotka-Flynn, Loretta B.; Hardten, David R.; Lin, Meng C.; Shtein, Roni M.; Hom, M. M.; Quintana, M.; Zermeno, A.; Pendleton, R.; McCluskey, D.; Amador, D.; Corona, I.; Wechter, V.; Childs, C.; Do, U.; Lerma, M.; Li, W.; Young, Z.; Yuen, T.; Dubiner, H.; Ambrosia, H.; Bowser, M.; Chen, P.; Fuller, C.; New, K.; Nguyen, T. V.; Seville, E.; Strait, D.; Wang, C.; Williams, S.; Weber, R.; Sutphin, J.; Bishara, M.; Bryan, A.; Ertel, A.; Green, K.; Pantoja, G.; Small, A.; Williamson, C.; Greiner, J.; DiPronio, E.; Lindsay, M.; McPherson, A.; Oliver, P.; Wu, R.; Dana, R.; Abud, T.; Adams, L.; Arnofsky, M.; Candlish, J.; Chilakamarri, P.; Ciolino, J.; Crandall, N.; Di Zazzo, A.; Fernandes, M.; Jafri, M.; Johnson, B.; Kheirkhah, A.; Kiebdaj, S.; Mullins, A.; Nova, M.; Satitpitakul, V.; Shao, C.; Suri, K.; Tadla, V.; Ujwala, S.; Yin, J.; Yu, M.; Hood, C.; Hussain, M.; Manno, E.; Rozek, L.; Baker, K.; Belsaas, A.; Berg, E.; Blakstad, A.; DauSchmidt, K.; Fallenstein, L.; Fahmy, A. M.; Fahmy, M. M.; Georges, G.; Harter, D. E.; Hauswirth, S. G.; Johnson, M.; Meshalkin, E.; Pelzer, R.; Tisdale, J.; Wick, J. C.; Tauber, J.; Hefter, M.; Silverstein, S.; Bentley, C.; Dominguez, E.; Kleinsasser, K.; Barry, B.; Kuklinski, E.; Amir, A.; Chen, N.; Oydanich, M.; Spahiu, V.; Vo, A.; Weinstein, M.; Vaz, T.; Hindman, H.; Aleese, R.; Czubinski, A.; Gagarinas, G.; McDowell, P.; O'Gara, G.; Steinmetz, K.; Bunya, V.; Bezzerides, M.; Caggiano, D.; Drossner, S.; Dupont, J.; Keiser, M.; Massaro, M.; Orlin, S.; O'Sullivan, R.; Christensen, M.; Adkins, H.; Brafford, R.; Ervin, C.; Grant, R.; Newman, C.; Shettle, L.; Shettle, D.; Cohen, S.; Rodman, D.; Caster, T.; Gupta, P.; Raghupathy, S.; Sayegh, R.; Shen, J.; Drutz, N.; Joyner, L.; Mathis, M.; Menghini, M.; Robinson, C.; Goldberg, D.; Jenkins, L.; Rodriguez, B.; Jones, J. P.; Thompson, N.; Wolstan, B.; Jones, M.; Lemaster, A.; Ransom-Chaney, J.; Rudy, W.; Hamrah, P.; Commodore, M.; Iyore, C.; Lazarev, L.; Mullen, L.; Pondelis, N.; Satsuma, C.; Jain, S.; Cowen, P.; Hallak, J.; Mun, C.; Toh, R.; Singh, I.; Lightfield, P.; Lowery, E.; Ornelas, S.; Sanka, R. K.; Saunders, B.; Mulqueeny, S. P.; Pohlmeier, M.; Aune, C.; Gabriel, H.; Walker, K. M.; Newsome, J.; Centers, R.; Farkouh, M.; Kim-Schulze, S.; Chapkin, R.; Greco, G.; Simopoulos, A.; Lashley, I.; Dentone, P.; Gadaria-Rathod, N.; Massingale, M.; Antonova, N.; Brightwell-Arnold, M.; Farrar, J.; Harkins, S.; Huang, J.; McWilliams, K.; Peskin, E.; Ryan, S.; Smolen, H.; Whearry, C.; Yu, Y.; Wei, Y.; Roy, Neeta; Epstein, S.; Rockwell, K.; Moser, A.; Jones, R. O.; Daniel, E.; Martin, E. R.; Ostroff, C. P.; Smith, E.; Kadakia, P. A.; Redford, M.; Wisniewski, S.; Brenna, T.; Christen, W. G.; Huang, J. F.; McCarthy, C. S.; Mayne, S. T.; Palta, M.; Schein, O. D.; Chuang, J.; Marchan, M.; Hao, T.; Heisler, C.; Hu, C.; Throop, C.; Moolchandani, V.

In: New England Journal of Medicine, Vol. 378, No. 18, 01.01.2018, p. 1681-1690.

Research output: Contribution to journalArticle

Asbell, P, Maguire, G, Pistilli, M, Ying, GS, Szczotka-Flynn, LB, Hardten, DR, Lin, MC, Shtein, RM, Hom, MM, Quintana, M, Zermeno, A, Pendleton, R, McCluskey, D, Amador, D, Corona, I, Wechter, V, Childs, C, Do, U, Lerma, M, Li, W, Young, Z, Yuen, T, Dubiner, H, Ambrosia, H, Bowser, M, Chen, P, Fuller, C, New, K, Nguyen, TV, Seville, E, Strait, D, Wang, C, Williams, S, Weber, R, Sutphin, J, Bishara, M, Bryan, A, Ertel, A, Green, K, Pantoja, G, Small, A, Williamson, C, Greiner, J, DiPronio, E, Lindsay, M, McPherson, A, Oliver, P, Wu, R, Dana, R, Abud, T, Adams, L, Arnofsky, M, Candlish, J, Chilakamarri, P, Ciolino, J, Crandall, N, Di Zazzo, A, Fernandes, M, Jafri, M, Johnson, B, Kheirkhah, A, Kiebdaj, S, Mullins, A, Nova, M, Satitpitakul, V, Shao, C, Suri, K, Tadla, V, Ujwala, S, Yin, J, Yu, M, Hood, C, Hussain, M, Manno, E, Rozek, L, Baker, K, Belsaas, A, Berg, E, Blakstad, A, DauSchmidt, K, Fallenstein, L, Fahmy, AM, Fahmy, MM, Georges, G, Harter, DE, Hauswirth, SG, Johnson, M, Meshalkin, E, Pelzer, R, Tisdale, J, Wick, JC, Tauber, J, Hefter, M, Silverstein, S, Bentley, C, Dominguez, E, Kleinsasser, K, Barry, B, Kuklinski, E, Amir, A, Chen, N, Oydanich, M, Spahiu, V, Vo, A, Weinstein, M, Vaz, T, Hindman, H, Aleese, R, Czubinski, A, Gagarinas, G, McDowell, P, O'Gara, G, Steinmetz, K, Bunya, V, Bezzerides, M, Caggiano, D, Drossner, S, Dupont, J, Keiser, M, Massaro, M, Orlin, S, O'Sullivan, R, Christensen, M, Adkins, H, Brafford, R, Ervin, C, Grant, R, Newman, C, Shettle, L, Shettle, D, Cohen, S, Rodman, D, Caster, T, Gupta, P, Raghupathy, S, Sayegh, R, Shen, J, Drutz, N, Joyner, L, Mathis, M, Menghini, M, Robinson, C, Goldberg, D, Jenkins, L, Rodriguez, B, Jones, JP, Thompson, N, Wolstan, B, Jones, M, Lemaster, A, Ransom-Chaney, J, Rudy, W, Hamrah, P, Commodore, M, Iyore, C, Lazarev, L, Mullen, L, Pondelis, N, Satsuma, C, Jain, S, Cowen, P, Hallak, J, Mun, C, Toh, R, Singh, I, Lightfield, P, Lowery, E, Ornelas, S, Sanka, RK, Saunders, B, Mulqueeny, SP, Pohlmeier, M, Aune, C, Gabriel, H, Walker, KM, Newsome, J, Centers, R, Farkouh, M, Kim-Schulze, S, Chapkin, R, Greco, G, Simopoulos, A, Lashley, I, Dentone, P, Gadaria-Rathod, N, Massingale, M, Antonova, N, Brightwell-Arnold, M, Farrar, J, Harkins, S, Huang, J, McWilliams, K, Peskin, E, Ryan, S, Smolen, H, Whearry, C, Yu, Y, Wei, Y, Roy, N, Epstein, S, Rockwell, K, Moser, A, Jones, RO, Daniel, E, Martin, ER, Ostroff, CP, Smith, E, Kadakia, PA, Redford, M, Wisniewski, S, Brenna, T, Christen, WG, Huang, JF, McCarthy, CS, Mayne, ST, Palta, M, Schein, OD, Chuang, J, Marchan, M, Hao, T, Heisler, C, Hu, C, Throop, C & Moolchandani, V 2018, 'n−3 Fatty acid supplementation for the treatment of dry eye disease', New England Journal of Medicine, vol. 378, no. 18, pp. 1681-1690. https://doi.org/10.1056/NEJMoa1709691
Asbell P, Maguire G, Pistilli M, Ying GS, Szczotka-Flynn LB, Hardten DR et al. n−3 Fatty acid supplementation for the treatment of dry eye disease. New England Journal of Medicine. 2018 Jan 1;378(18):1681-1690. https://doi.org/10.1056/NEJMoa1709691
Asbell, Penny ; Maguire, G. ; Pistilli, Maxwell ; Ying, Gui Shuang ; Szczotka-Flynn, Loretta B. ; Hardten, David R. ; Lin, Meng C. ; Shtein, Roni M. ; Hom, M. M. ; Quintana, M. ; Zermeno, A. ; Pendleton, R. ; McCluskey, D. ; Amador, D. ; Corona, I. ; Wechter, V. ; Childs, C. ; Do, U. ; Lerma, M. ; Li, W. ; Young, Z. ; Yuen, T. ; Dubiner, H. ; Ambrosia, H. ; Bowser, M. ; Chen, P. ; Fuller, C. ; New, K. ; Nguyen, T. V. ; Seville, E. ; Strait, D. ; Wang, C. ; Williams, S. ; Weber, R. ; Sutphin, J. ; Bishara, M. ; Bryan, A. ; Ertel, A. ; Green, K. ; Pantoja, G. ; Small, A. ; Williamson, C. ; Greiner, J. ; DiPronio, E. ; Lindsay, M. ; McPherson, A. ; Oliver, P. ; Wu, R. ; Dana, R. ; Abud, T. ; Adams, L. ; Arnofsky, M. ; Candlish, J. ; Chilakamarri, P. ; Ciolino, J. ; Crandall, N. ; Di Zazzo, A. ; Fernandes, M. ; Jafri, M. ; Johnson, B. ; Kheirkhah, A. ; Kiebdaj, S. ; Mullins, A. ; Nova, M. ; Satitpitakul, V. ; Shao, C. ; Suri, K. ; Tadla, V. ; Ujwala, S. ; Yin, J. ; Yu, M. ; Hood, C. ; Hussain, M. ; Manno, E. ; Rozek, L. ; Baker, K. ; Belsaas, A. ; Berg, E. ; Blakstad, A. ; DauSchmidt, K. ; Fallenstein, L. ; Fahmy, A. M. ; Fahmy, M. M. ; Georges, G. ; Harter, D. E. ; Hauswirth, S. G. ; Johnson, M. ; Meshalkin, E. ; Pelzer, R. ; Tisdale, J. ; Wick, J. C. ; Tauber, J. ; Hefter, M. ; Silverstein, S. ; Bentley, C. ; Dominguez, E. ; Kleinsasser, K. ; Barry, B. ; Kuklinski, E. ; Amir, A. ; Chen, N. ; Oydanich, M. ; Spahiu, V. ; Vo, A. ; Weinstein, M. ; Vaz, T. ; Hindman, H. ; Aleese, R. ; Czubinski, A. ; Gagarinas, G. ; McDowell, P. ; O'Gara, G. ; Steinmetz, K. ; Bunya, V. ; Bezzerides, M. ; Caggiano, D. ; Drossner, S. ; Dupont, J. ; Keiser, M. ; Massaro, M. ; Orlin, S. ; O'Sullivan, R. ; Christensen, M. ; Adkins, H. ; Brafford, R. ; Ervin, C. ; Grant, R. ; Newman, C. ; Shettle, L. ; Shettle, D. ; Cohen, S. ; Rodman, D. ; Caster, T. ; Gupta, P. ; Raghupathy, S. ; Sayegh, R. ; Shen, J. ; Drutz, N. ; Joyner, L. ; Mathis, M. ; Menghini, M. ; Robinson, C. ; Goldberg, D. ; Jenkins, L. ; Rodriguez, B. ; Jones, J. P. ; Thompson, N. ; Wolstan, B. ; Jones, M. ; Lemaster, A. ; Ransom-Chaney, J. ; Rudy, W. ; Hamrah, P. ; Commodore, M. ; Iyore, C. ; Lazarev, L. ; Mullen, L. ; Pondelis, N. ; Satsuma, C. ; Jain, S. ; Cowen, P. ; Hallak, J. ; Mun, C. ; Toh, R. ; Singh, I. ; Lightfield, P. ; Lowery, E. ; Ornelas, S. ; Sanka, R. K. ; Saunders, B. ; Mulqueeny, S. P. ; Pohlmeier, M. ; Aune, C. ; Gabriel, H. ; Walker, K. M. ; Newsome, J. ; Centers, R. ; Farkouh, M. ; Kim-Schulze, S. ; Chapkin, R. ; Greco, G. ; Simopoulos, A. ; Lashley, I. ; Dentone, P. ; Gadaria-Rathod, N. ; Massingale, M. ; Antonova, N. ; Brightwell-Arnold, M. ; Farrar, J. ; Harkins, S. ; Huang, J. ; McWilliams, K. ; Peskin, E. ; Ryan, S. ; Smolen, H. ; Whearry, C. ; Yu, Y. ; Wei, Y. ; Roy, Neeta ; Epstein, S. ; Rockwell, K. ; Moser, A. ; Jones, R. O. ; Daniel, E. ; Martin, E. R. ; Ostroff, C. P. ; Smith, E. ; Kadakia, P. A. ; Redford, M. ; Wisniewski, S. ; Brenna, T. ; Christen, W. G. ; Huang, J. F. ; McCarthy, C. S. ; Mayne, S. T. ; Palta, M. ; Schein, O. D. ; Chuang, J. ; Marchan, M. ; Hao, T. ; Heisler, C. ; Hu, C. ; Throop, C. ; Moolchandani, V. / n−3 Fatty acid supplementation for the treatment of dry eye disease. In: New England Journal of Medicine. 2018 ; Vol. 378, No. 18. pp. 1681-1690.
@article{66cf881448f74086b56e87227501aef0,
title = "n−3 Fatty acid supplementation for the treatment of dry eye disease",
abstract = "BACKGROUND Dry eye disease is a common chronic condition that is characterized by ocular discomfort and visual disturbances that decrease quality of life. Many clinicians recommend the use of supplements of n−3 fatty acids (often called omega-3 fatty acids) to relieve symptoms. METHODS In a multicenter, double-blind clinical trial, we randomly assigned patients with moderate-to-severe dry eye disease to receive a daily oral dose of 3000 mg of fish-derived n−3 eicosapentaenoic and docosahexaenoic acids (active supplement group) or an olive oil placebo (placebo group). The primary outcome was the mean change from baseline in the score on the Ocular Surface Disease Index (OSDI; scores range from 0 to 100, with higher scores indicating greater symptom severity), which was based on the mean of scores obtained at 6 and 12 months. Secondary outcomes included mean changes per eye in the conjunctival staining score (ranging from 0 to 6) and the corneal staining score (ranging from 0 to 15), with higher scores indicating more severe damage to the ocular surface, as well as mean changes in the tear break-up time (seconds between a blink and gaps in the tear film) and the result on Schirmer's test (length of wetting of paper strips placed on the lower eyelid), with lower values indicating more severe signs. RESULTS A total of 349 patients were assigned to the active supplement group and 186 to the placebo group; the primary analysis included 329 and 170 patients, respectively. The mean change in the OSDI score was not significantly different between the active supplement group and the placebo group (−13.9 points and −12.5 points, respectively; mean difference in change after imputation of missing data, −1.9 points; 95{\%} confidence interval [CI], −5.0 to 1.1; P=0.21). This result was consistent across prespecified subgroups. There were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change, 0.0 points; 95{\%} CI, −0.2 to 0.1), corneal staining score (0.1 point; 95{\%} CI, −0.2 to 0.4), tear break-up time (0.2 seconds; 95{\%} CI, −0.1 to 0.5), and result on Schirmer's test (0.0 mm; 95{\%} CI, −0.8 to 0.9). At 12 months, the rate of adherence to treatment in the active supplement group was 85.2{\%}, according to the level of n−3 fatty acids in red cells. Rates of adverse events were similar in the two trial groups. CONCLUSIONS Among patients with dry eye disease, those who were randomly assigned to receive supplements containing 3000 mg of n−3 fatty acids for 12 months did not have significantly better outcomes than those who were assigned to receive placebo. (Funded by the National Eye Institute, National Institutes of Health; DREAM ClinicalTrials.gov number, NCT02128763).",
author = "Penny Asbell and G. Maguire and Maxwell Pistilli and Ying, {Gui Shuang} and Szczotka-Flynn, {Loretta B.} and Hardten, {David R.} and Lin, {Meng C.} and Shtein, {Roni M.} and Hom, {M. M.} and M. Quintana and A. Zermeno and R. Pendleton and D. McCluskey and D. Amador and I. Corona and V. Wechter and C. Childs and U. Do and M. Lerma and W. Li and Z. Young and T. Yuen and H. Dubiner and H. Ambrosia and M. Bowser and P. Chen and C. Fuller and K. New and Nguyen, {T. V.} and E. Seville and D. Strait and C. Wang and S. Williams and R. Weber and J. Sutphin and M. Bishara and A. Bryan and A. Ertel and K. Green and G. Pantoja and A. Small and C. Williamson and J. Greiner and E. DiPronio and M. Lindsay and A. McPherson and P. Oliver and R. Wu and R. Dana and T. Abud and L. Adams and M. Arnofsky and J. Candlish and P. Chilakamarri and J. Ciolino and N. Crandall and {Di Zazzo}, A. and M. Fernandes and M. Jafri and B. Johnson and A. Kheirkhah and S. Kiebdaj and A. Mullins and M. Nova and V. Satitpitakul and C. Shao and K. Suri and V. Tadla and S. Ujwala and J. Yin and M. Yu and C. Hood and M. Hussain and E. Manno and L. Rozek and K. Baker and A. Belsaas and E. Berg and A. Blakstad and K. DauSchmidt and L. Fallenstein and Fahmy, {A. M.} and Fahmy, {M. M.} and G. Georges and Harter, {D. E.} and Hauswirth, {S. G.} and M. Johnson and E. Meshalkin and R. Pelzer and J. Tisdale and Wick, {J. C.} and J. Tauber and M. Hefter and S. Silverstein and C. Bentley and E. Dominguez and K. Kleinsasser and B. Barry and E. Kuklinski and A. Amir and N. Chen and M. Oydanich and V. Spahiu and A. Vo and M. Weinstein and T. Vaz and H. Hindman and R. Aleese and A. Czubinski and G. Gagarinas and P. McDowell and G. O'Gara and K. Steinmetz and V. Bunya and M. Bezzerides and D. Caggiano and S. Drossner and J. Dupont and M. Keiser and M. Massaro and S. Orlin and R. O'Sullivan and M. Christensen and H. Adkins and R. Brafford and C. Ervin and R. Grant and C. Newman and L. Shettle and D. Shettle and S. Cohen and D. Rodman and T. Caster and P. Gupta and S. Raghupathy and R. Sayegh and J. Shen and N. Drutz and L. Joyner and M. Mathis and M. Menghini and C. Robinson and D. Goldberg and L. Jenkins and B. Rodriguez and Jones, {J. P.} and N. Thompson and B. Wolstan and M. Jones and A. Lemaster and J. Ransom-Chaney and W. Rudy and P. Hamrah and M. Commodore and C. Iyore and L. Lazarev and L. Mullen and N. Pondelis and C. Satsuma and S. Jain and P. Cowen and J. Hallak and C. Mun and R. Toh and I. Singh and P. Lightfield and E. Lowery and S. Ornelas and Sanka, {R. K.} and B. Saunders and Mulqueeny, {S. P.} and M. Pohlmeier and C. Aune and H. Gabriel and Walker, {K. M.} and J. Newsome and R. Centers and M. Farkouh and S. Kim-Schulze and R. Chapkin and G. Greco and A. Simopoulos and I. Lashley and P. Dentone and N. Gadaria-Rathod and M. Massingale and N. Antonova and M. Brightwell-Arnold and J. Farrar and S. Harkins and J. Huang and K. McWilliams and E. Peskin and S. Ryan and H. Smolen and C. Whearry and Y. Yu and Y. Wei and Neeta Roy and S. Epstein and K. Rockwell and A. Moser and Jones, {R. O.} and E. Daniel and Martin, {E. R.} and Ostroff, {C. P.} and E. Smith and Kadakia, {P. A.} and M. Redford and S. Wisniewski and T. Brenna and Christen, {W. G.} and Huang, {J. F.} and McCarthy, {C. S.} and Mayne, {S. T.} and M. Palta and Schein, {O. D.} and J. Chuang and M. Marchan and T. Hao and C. Heisler and C. Hu and C. Throop and V. Moolchandani",
year = "2018",
month = "1",
day = "1",
doi = "10.1056/NEJMoa1709691",
language = "English (US)",
volume = "378",
pages = "1681--1690",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "18",

}

TY - JOUR

T1 - n−3 Fatty acid supplementation for the treatment of dry eye disease

AU - Asbell, Penny

AU - Maguire, G.

AU - Pistilli, Maxwell

AU - Ying, Gui Shuang

AU - Szczotka-Flynn, Loretta B.

AU - Hardten, David R.

AU - Lin, Meng C.

AU - Shtein, Roni M.

AU - Hom, M. M.

AU - Quintana, M.

AU - Zermeno, A.

AU - Pendleton, R.

AU - McCluskey, D.

AU - Amador, D.

AU - Corona, I.

AU - Wechter, V.

AU - Childs, C.

AU - Do, U.

AU - Lerma, M.

AU - Li, W.

AU - Young, Z.

AU - Yuen, T.

AU - Dubiner, H.

AU - Ambrosia, H.

AU - Bowser, M.

AU - Chen, P.

AU - Fuller, C.

AU - New, K.

AU - Nguyen, T. V.

AU - Seville, E.

AU - Strait, D.

AU - Wang, C.

AU - Williams, S.

AU - Weber, R.

AU - Sutphin, J.

AU - Bishara, M.

AU - Bryan, A.

AU - Ertel, A.

AU - Green, K.

AU - Pantoja, G.

AU - Small, A.

AU - Williamson, C.

AU - Greiner, J.

AU - DiPronio, E.

AU - Lindsay, M.

AU - McPherson, A.

AU - Oliver, P.

AU - Wu, R.

AU - Dana, R.

AU - Abud, T.

AU - Adams, L.

AU - Arnofsky, M.

AU - Candlish, J.

AU - Chilakamarri, P.

AU - Ciolino, J.

AU - Crandall, N.

AU - Di Zazzo, A.

AU - Fernandes, M.

AU - Jafri, M.

AU - Johnson, B.

AU - Kheirkhah, A.

AU - Kiebdaj, S.

AU - Mullins, A.

AU - Nova, M.

AU - Satitpitakul, V.

AU - Shao, C.

AU - Suri, K.

AU - Tadla, V.

AU - Ujwala, S.

AU - Yin, J.

AU - Yu, M.

AU - Hood, C.

AU - Hussain, M.

AU - Manno, E.

AU - Rozek, L.

AU - Baker, K.

AU - Belsaas, A.

AU - Berg, E.

AU - Blakstad, A.

AU - DauSchmidt, K.

AU - Fallenstein, L.

AU - Fahmy, A. M.

AU - Fahmy, M. M.

AU - Georges, G.

AU - Harter, D. E.

AU - Hauswirth, S. G.

AU - Johnson, M.

AU - Meshalkin, E.

AU - Pelzer, R.

AU - Tisdale, J.

AU - Wick, J. C.

AU - Tauber, J.

AU - Hefter, M.

AU - Silverstein, S.

AU - Bentley, C.

AU - Dominguez, E.

AU - Kleinsasser, K.

AU - Barry, B.

AU - Kuklinski, E.

AU - Amir, A.

AU - Chen, N.

AU - Oydanich, M.

AU - Spahiu, V.

AU - Vo, A.

AU - Weinstein, M.

AU - Vaz, T.

AU - Hindman, H.

AU - Aleese, R.

AU - Czubinski, A.

AU - Gagarinas, G.

AU - McDowell, P.

AU - O'Gara, G.

AU - Steinmetz, K.

AU - Bunya, V.

AU - Bezzerides, M.

AU - Caggiano, D.

AU - Drossner, S.

AU - Dupont, J.

AU - Keiser, M.

AU - Massaro, M.

AU - Orlin, S.

AU - O'Sullivan, R.

AU - Christensen, M.

AU - Adkins, H.

AU - Brafford, R.

AU - Ervin, C.

AU - Grant, R.

AU - Newman, C.

AU - Shettle, L.

AU - Shettle, D.

AU - Cohen, S.

AU - Rodman, D.

AU - Caster, T.

AU - Gupta, P.

AU - Raghupathy, S.

AU - Sayegh, R.

AU - Shen, J.

AU - Drutz, N.

AU - Joyner, L.

AU - Mathis, M.

AU - Menghini, M.

AU - Robinson, C.

AU - Goldberg, D.

AU - Jenkins, L.

AU - Rodriguez, B.

AU - Jones, J. P.

AU - Thompson, N.

AU - Wolstan, B.

AU - Jones, M.

AU - Lemaster, A.

AU - Ransom-Chaney, J.

AU - Rudy, W.

AU - Hamrah, P.

AU - Commodore, M.

AU - Iyore, C.

AU - Lazarev, L.

AU - Mullen, L.

AU - Pondelis, N.

AU - Satsuma, C.

AU - Jain, S.

AU - Cowen, P.

AU - Hallak, J.

AU - Mun, C.

AU - Toh, R.

AU - Singh, I.

AU - Lightfield, P.

AU - Lowery, E.

AU - Ornelas, S.

AU - Sanka, R. K.

AU - Saunders, B.

AU - Mulqueeny, S. P.

AU - Pohlmeier, M.

AU - Aune, C.

AU - Gabriel, H.

AU - Walker, K. M.

AU - Newsome, J.

AU - Centers, R.

AU - Farkouh, M.

AU - Kim-Schulze, S.

AU - Chapkin, R.

AU - Greco, G.

AU - Simopoulos, A.

AU - Lashley, I.

AU - Dentone, P.

AU - Gadaria-Rathod, N.

AU - Massingale, M.

AU - Antonova, N.

AU - Brightwell-Arnold, M.

AU - Farrar, J.

AU - Harkins, S.

AU - Huang, J.

AU - McWilliams, K.

AU - Peskin, E.

AU - Ryan, S.

AU - Smolen, H.

AU - Whearry, C.

AU - Yu, Y.

AU - Wei, Y.

AU - Roy, Neeta

AU - Epstein, S.

AU - Rockwell, K.

AU - Moser, A.

AU - Jones, R. O.

AU - Daniel, E.

AU - Martin, E. R.

AU - Ostroff, C. P.

AU - Smith, E.

AU - Kadakia, P. A.

AU - Redford, M.

AU - Wisniewski, S.

AU - Brenna, T.

AU - Christen, W. G.

AU - Huang, J. F.

AU - McCarthy, C. S.

AU - Mayne, S. T.

AU - Palta, M.

AU - Schein, O. D.

AU - Chuang, J.

AU - Marchan, M.

AU - Hao, T.

AU - Heisler, C.

AU - Hu, C.

AU - Throop, C.

AU - Moolchandani, V.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - BACKGROUND Dry eye disease is a common chronic condition that is characterized by ocular discomfort and visual disturbances that decrease quality of life. Many clinicians recommend the use of supplements of n−3 fatty acids (often called omega-3 fatty acids) to relieve symptoms. METHODS In a multicenter, double-blind clinical trial, we randomly assigned patients with moderate-to-severe dry eye disease to receive a daily oral dose of 3000 mg of fish-derived n−3 eicosapentaenoic and docosahexaenoic acids (active supplement group) or an olive oil placebo (placebo group). The primary outcome was the mean change from baseline in the score on the Ocular Surface Disease Index (OSDI; scores range from 0 to 100, with higher scores indicating greater symptom severity), which was based on the mean of scores obtained at 6 and 12 months. Secondary outcomes included mean changes per eye in the conjunctival staining score (ranging from 0 to 6) and the corneal staining score (ranging from 0 to 15), with higher scores indicating more severe damage to the ocular surface, as well as mean changes in the tear break-up time (seconds between a blink and gaps in the tear film) and the result on Schirmer's test (length of wetting of paper strips placed on the lower eyelid), with lower values indicating more severe signs. RESULTS A total of 349 patients were assigned to the active supplement group and 186 to the placebo group; the primary analysis included 329 and 170 patients, respectively. The mean change in the OSDI score was not significantly different between the active supplement group and the placebo group (−13.9 points and −12.5 points, respectively; mean difference in change after imputation of missing data, −1.9 points; 95% confidence interval [CI], −5.0 to 1.1; P=0.21). This result was consistent across prespecified subgroups. There were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change, 0.0 points; 95% CI, −0.2 to 0.1), corneal staining score (0.1 point; 95% CI, −0.2 to 0.4), tear break-up time (0.2 seconds; 95% CI, −0.1 to 0.5), and result on Schirmer's test (0.0 mm; 95% CI, −0.8 to 0.9). At 12 months, the rate of adherence to treatment in the active supplement group was 85.2%, according to the level of n−3 fatty acids in red cells. Rates of adverse events were similar in the two trial groups. CONCLUSIONS Among patients with dry eye disease, those who were randomly assigned to receive supplements containing 3000 mg of n−3 fatty acids for 12 months did not have significantly better outcomes than those who were assigned to receive placebo. (Funded by the National Eye Institute, National Institutes of Health; DREAM ClinicalTrials.gov number, NCT02128763).

AB - BACKGROUND Dry eye disease is a common chronic condition that is characterized by ocular discomfort and visual disturbances that decrease quality of life. Many clinicians recommend the use of supplements of n−3 fatty acids (often called omega-3 fatty acids) to relieve symptoms. METHODS In a multicenter, double-blind clinical trial, we randomly assigned patients with moderate-to-severe dry eye disease to receive a daily oral dose of 3000 mg of fish-derived n−3 eicosapentaenoic and docosahexaenoic acids (active supplement group) or an olive oil placebo (placebo group). The primary outcome was the mean change from baseline in the score on the Ocular Surface Disease Index (OSDI; scores range from 0 to 100, with higher scores indicating greater symptom severity), which was based on the mean of scores obtained at 6 and 12 months. Secondary outcomes included mean changes per eye in the conjunctival staining score (ranging from 0 to 6) and the corneal staining score (ranging from 0 to 15), with higher scores indicating more severe damage to the ocular surface, as well as mean changes in the tear break-up time (seconds between a blink and gaps in the tear film) and the result on Schirmer's test (length of wetting of paper strips placed on the lower eyelid), with lower values indicating more severe signs. RESULTS A total of 349 patients were assigned to the active supplement group and 186 to the placebo group; the primary analysis included 329 and 170 patients, respectively. The mean change in the OSDI score was not significantly different between the active supplement group and the placebo group (−13.9 points and −12.5 points, respectively; mean difference in change after imputation of missing data, −1.9 points; 95% confidence interval [CI], −5.0 to 1.1; P=0.21). This result was consistent across prespecified subgroups. There were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change, 0.0 points; 95% CI, −0.2 to 0.1), corneal staining score (0.1 point; 95% CI, −0.2 to 0.4), tear break-up time (0.2 seconds; 95% CI, −0.1 to 0.5), and result on Schirmer's test (0.0 mm; 95% CI, −0.8 to 0.9). At 12 months, the rate of adherence to treatment in the active supplement group was 85.2%, according to the level of n−3 fatty acids in red cells. Rates of adverse events were similar in the two trial groups. CONCLUSIONS Among patients with dry eye disease, those who were randomly assigned to receive supplements containing 3000 mg of n−3 fatty acids for 12 months did not have significantly better outcomes than those who were assigned to receive placebo. (Funded by the National Eye Institute, National Institutes of Health; DREAM ClinicalTrials.gov number, NCT02128763).

UR - http://www.scopus.com/inward/record.url?scp=85046624345&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85046624345&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1709691

DO - 10.1056/NEJMoa1709691

M3 - Article

VL - 378

SP - 1681

EP - 1690

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 18

ER -