The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease
This was a Phase 2b, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 01 nasal spray in adult subjects with DED. The study randomized 182 subjects, at least 22 years of age, who had a physician's diagnosis of dry eye disease and met all other study eligibility criteria to receive an application of OC-01 or placebo twice daily (BID) for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
182
OC-01 (varenicline) nasal spray
Placebo
Newport Beach
Newport Beach, California, United States
Indianapolis
Indianapolis, Indiana, United States
Andover
Andover, Massachusetts, United States
Mean Change in Schirmer's Test Score From Baseline to 28 Days
The primary end point was the change in anesthetized Schirmer's Test Score (STS) from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.
Time frame: 28 Days [Visit 1 (baseline) and Visit 5 (28 days)]
Change From Baseline in Eye Dryness Score From Baseline to Day 28
Change in Eye Dryness Score from baseline to 28 days. Eye Dryness (EDS) on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.
Time frame: 28 days [Visit 1 (baseline and Visit 5 (28 days)]
Change From Baseline to Day 21 in Eye Dryness Score at 5 Minutes Post Treatment in the CAE.
Change from baseline to Day 21 in Eye Dryness Score at 5 minutes post treatment in the CAE. Eye Dryness (EDS) on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.
Time frame: 21 days [Visit 1 (baseline) and Visit 4 (21 days)]
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