DREAM Extension Study Reinforces Primary Trial Results, Optometrists Remain Skeptical
In May 2018, the DREAM study primary trial concluded that oral omega-3 fatty acids were no more effective than placebo for the treatment of dry eye. Now results from the 12-month DREAM Extension study confirm that the findings are consistent with the trial.
DREAM examined 535 patients (active supplement group: 349 patients, placebo group: 186 patients). Primary analysis included 329 and 170 patients, respectively. The multicenter, double-blind clinical trial randomly assigned patients with moderate-to-severe dry eye to receive a daily oral dose of 3000 mg of fish-derived omega-3 (active supplement group) or an olive oil placebo (placebo group).
At conclusion of the trial, mean change in OSDI score was not significantly different between groups (−13.9 points for the active supplement group and −12.5 points for the placebo group). There were also no significant differences between groups in mean changes from baseline in the conjunctival staining score (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 Schirmer’s test score (0.0 mm; 95% CI, −0.8 to 0.9).
The DREAM Extension study added an additional year of treatment to analyze long-term efficacy. During this second year, patients either continued or discontinued omega-3 supplementation. Patients were eligible for the DREAM Extension study if they were assigned to the active supplement group in the primary trial and completed 12-month follow-up; forty-three patients participated in the DREAM Extension study and were randomly selected to continue treatment or switched to placebo.
Results showed that the OSDI increased slightly in both groups, but there was no statistically significant difference between groups regarding conjunctival staining scores, corneal staining scores, tear break-up time, and Schirmer’s test scores.
However, some optometrists caution abiding by the findings. Paul Karpecki, OD, Lexington, KY, noted, “Some people think the study results mean fish oil doesn’t work for dry eye, and that’s not the case. The fish oil treatment arm had a phenomenal statistical improvement from baseline. So, fish oil does work, and it’s very effective.”
One of the main concerns is that the study’s inclusion criteria did not accurately mimic real-world clinical application because they were too broad. Dr. Karpecki added, “It’s a mystery, but with a p value of 0.005, I find it hard to believe it could all be a placebo effect. My only hypothesis is that the ‘real-world’ study design led to murky data, so the dry eye improvements were more due to outside factors that were unaccounted for.”
Others feel the data should not be completely ignored. Whitney Hauser, OD, of Southern College of Optometry in Memphis, TN, thinks nutraceuticals could play a key role in dry eye through evolving formulations, concluding, “The DREAM study opened a dialogue about nutrition and supplementation in dry eye. I don’t think it’s the end of the conversation but rather the beginning.”
Krader CG. DREAM Extension study supports primary trial conclusion. Ophthalmology Times. https://www.ophthalmologytimes.com/dry-eye/dream-extension-study-supports-primary-trial-conclusion. Updated July 25, 2019.
The Dry Eye Assessment and Management Study Research Group. n−3 fatty acid supplementation for the treatment of dry eye disease. N Engl J Med. 2018;378:1681-1690. doi: 10.1056/NEJMoa1709691.
Cole J. Did the DREAM study change your thinking? Review of Optometry. https://www.reviewofoptometry.com/article/did-the-dream-study-change-your-thinking. Updated May 16, 2019.