Abstract
Purpose :
Treatment of dry eye disease (DED) with omega-3 fatty acid (ω3) has shown comparable results to placebo. To further evaluate the progression of DED symptoms and signs over 2 years, we performed a secondary analysis of data from 43 DREAM participants with moderate-to-severe DED.
Methods :
Participants who were randomized in the first year to the ω3 (3000 mg daily) treatment group were re-randomized in the second year to either continue with ω3 (22 subjects) or switch to placebo (21 subjects). At baseline, 3, 6, 12, 18, and 24 months, DED symptoms were evaluated by the Ocular Surface Disease Index (OSDI) and the Brief Ocular Discomfort Index (BODI). DED signs were assessed in each eye through evaluating conjunctival staining, corneal staining, tear break-up time (TBUT), Schirmer’s testing, meibomian gland dysfunction (MGD), tear osmolarity, and keratography measures (non-invasive keratograph break-up time, tear meniscus height, bulbar redness score, and loss of meibography gland in upper and lower lids). Because the DREAM study had found no significant differences in the sign and symptoms between ω3 and placebo, we performed an analysis for the data from all 43 participants together to assess for any changes in DED symptoms and signs over 2 years.
Results :
At 3 months after ω3 treatment, there were significant improvements in OSDI and BODI scores (all p<0.001) and less use of artificial tears or gel (p=0.02), but between 6 and 24 months, no significant changes in DED symptoms and treatments were observed (all p≥0.09, Table 1). Except for a significant change in conjunctival staining score over 2 years (p=0.001), there were no significant changes over 2 years in corneal staining (p=0.32), TBUT (p=0.43), Schirmer test (p=0.09), meibomian gland dysfunction (p=0.15), tear osmolarity (p=0.57) and non-invasive keratography measures (all p≥0.07, Table 2).
Conclusions :
We observed a significant improvement in subjective measures of DED symptoms in the first 3 months after ω3 treatment, likely due to a placebo effect or regression to the mean. DED symptoms remained stable after 3 months. Other than the conjunctival staining score, no significant changes were observed in objective measures of DED signs over 2 years. Thus, these results do not support progression of DED over the 2 years of observation. Future clinical trials of DED should consider the short-term placebo effect of treatments on DED symptoms.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.