The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline solution) Nasal Spray as compared to placebo (vehicle) on signs and symptoms of dry eye disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
340
Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days
Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Schirmer's Test Score
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline
Time frame: 28 days
Mean change from Baseline in Schirmer's Test Score (STS)
Schirmer's test scores are from 0-35 mm where a higher score is indicative of a better outcome.
Time frame: 28 days
Mean change from Baseline in Eye Dryness Score (EDS)
Eye dryness score is assessed on a visual analogue scale with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome
Time frame: 28 days/ 14 days/ 7days
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