Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2020 Jan;18(1):47-55.
doi: 10.1016/j.jtos.2019.08.002. Epub 2019 Aug 16.

The Dry Eye Assessment and Management (DREAM) extension study - A randomized clinical trial of withdrawal of supplementation with omega-3 fatty acid in patients with dry eye disease

Munira Hussain  1 , Roni M Shtein  1 , Maxwell Pistilli  2 , Maureen G Maguire  3 , Marko Oydanich  4 , Penny A Asbell  5 ; DREAM Study Research Group
Affiliations
Randomized Controlled Trial

The Dry Eye Assessment and Management (DREAM) extension study - A randomized clinical trial of withdrawal of supplementation with omega-3 fatty acid in patients with dry eye disease

Munira Hussain et al. Ocul Surf. 2020 Jan.

Abstract

Purpose: To determine effects of continued or discontinued use of omega-3 (ω3) fatty acid supplements through a randomized withdrawal trial among patients assigned to ω3 supplements in the first year of the DREAM study.

Methods: Patients who were initially assigned to ω3 (3000 mg) for 12 months in the primary trial were randomized 1:1 to ω3 active supplements or placebos (refined olive oil) for 12 more months. The primary outcome was change in the Ocular Surface Disease Index (OSDI) score. Secondary outcomes included change in conjunctival staining, corneal staining, tear break-up time, Schirmer test, and adverse events.

Results: Among 22 patients assigned to ω3 and 21 to placebo supplements, the mean change in OSDI score between month 12 and 24 was similar between treatment groups (mean difference in change -0.6 points, 95% confidence interval [CI], (-10.7, 9.5), p = 0.91). There were no significant differences between groups in mean change in conjunctival staining (difference in mean change -0.5 points; 95% CI (-1.2, 0.3)), corneal staining (-0.3 points; 95% CI (-1.2, 0.3)), tear break-up time (-0.8 s; 95% CI (-2.6, 0.9)) and Schirmer test (0.6 mm, 95% CI (-2.0, 3.2)). Rates of adverse events were similar in both groups.

Conclusion: Among patients who received ω3 supplements for 12 months in the primary trial, those discontinuing use of ω3 for an additional 12 months did not have significantly worse outcomes compared to those who continued use of ω3. ClinicalTrials.gov number NCT02128763.

Keywords: Dry eye disease; Omega-3 fatty acids; Randomized clinical trial.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Schematic overview of the DREAM primary and extension trials
Figure 2.
Figure 2.
Ocular Surface Disease Index (OSDI) scores over time. Box and whisker plots: Box upper and lower edges correspond to the 75th and 25th percentiles, respectively. Within the box, the asterisk corresponds to the mean value and the line corresponds to the 50th percentile (median). Ends of whiskers correspond to the lowest score within 1.5 times the interquartile range of the 25th percentile and the highest score within 1.5 times the interquartile range of 75th percentile. Each circle outside of the whiskers corresponds to one score.
Figure 3.
Figure 3.
Signs of dry eye disease over time by treatment group. Mean values and associated 95% confidence intervals for signs of dry eye disease by treatment group, over time. Dotted lines connect values prior to randomization in the extension trial. A. Conjunctival staining; B. Corneal staining; C. Tear break-up time; D. Shirmer test.
Figure 3.
Figure 3.
Signs of dry eye disease over time by treatment group. Mean values and associated 95% confidence intervals for signs of dry eye disease by treatment group, over time. Dotted lines connect values prior to randomization in the extension trial. A. Conjunctival staining; B. Corneal staining; C. Tear break-up time; D. Shirmer test.
Figure 3.
Figure 3.
Signs of dry eye disease over time by treatment group. Mean values and associated 95% confidence intervals for signs of dry eye disease by treatment group, over time. Dotted lines connect values prior to randomization in the extension trial. A. Conjunctival staining; B. Corneal staining; C. Tear break-up time; D. Shirmer test.
Figure 3.
Figure 3.
Signs of dry eye disease over time by treatment group. Mean values and associated 95% confidence intervals for signs of dry eye disease by treatment group, over time. Dotted lines connect values prior to randomization in the extension trial. A. Conjunctival staining; B. Corneal staining; C. Tear break-up time; D. Shirmer test.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Pflugfelder SC, Geerling G, Kinoshita S, Lemp MA, McCulley J, Nelson D, et al. Management and therapy of dry eye disease: report of the management and therapy subcommittee of the International Dry Eye WorkShop (2007). Ocular Surf 2007;5:163–78. - PubMed
    1. Belmonte C, Nichols JJ, Cox SM, Brock JA, Begley CG, Bereiter DA, et al. TFOS DEWS II pain and sensation report. Ocul Surf 2017;15:404–37. - PMC - PubMed
    1. Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, et al. TFOS DEWS II Definition and Classification Report. Ocul Surf 2017;15:276–83. - PubMed
    1. Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, et al. TFOS DEWS II Epidemiology Report. Ocul Surf 2017;15:334–65. - PubMed
    1. Wei Y, Asbell PA. The core mechanism of dry eye disease is inflammation. Eye Contact Lens 2014;40:248–56. - PMC - PubMed

Publication types

Substances

Associated data