A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease

Participants: ≥18yo with history and clinical diagnosis of Dry Eye Disease
-global symptom score of 40 or more (range: 0–100)
-lissamine green conjunctival staining score of ≥3 and ≤9 (range: 0–12) in at least 1 eye

n=744 patients

Intervention:

Group 1: OTX-101 0.09% (twice daily)
Group 2: placebo

There were significant improvements observed in corneal and conjunctival staining.

The global symptom score was reduced by 30% from baseline in both groups, but no significant difference between groups was observed.