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 3, multicenter, randomized, controlled, double-masked (including subjects, Investigators, study site personnel, and Sponsor personnel) study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray 0.6 mg/mL and 1.2 mg/mL in adult participants with DED. The study randomized 758 subjects at least 22 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria to receive OC-01 (varenicline) nasal spray or placebo twice daily (BID) for 28 days with three additional long-term follow-up visits at 6 weeks, 6 months, and 12 months. Participants who terminated from the study during the treatment period were asked to complete safety assessments (if the participants agree) prior to study exit. Participants who were terminated early from the study were not replaced
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
758
OC-01 (varenicline) nasal spray
Placebo (vehicle) nasal spray
Phoenix
Phoenix, Arizona, United States
New Port Beach
Newport Beach, California, United States
Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)
The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Time frame: 28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes
Change in Eye Dryness Score Eye from baseline in CAE at 4 Weeks at 5 minutes post treatment. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.
Time frame: 28 Days [Visit 1 (baseline) and Visit 4a (28 days)]
Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28
Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.
Time frame: 28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28
Change in Schirmer test score from baseline to Day 28. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Time frame: 28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2
Chang in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better otucome.
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Fort Collins
Fort Collins, Colorado, United States
Waterbury
Waterbury, Connecticut, United States
Delray Beach
Delray Beach, Florida, United States
Indianapolis
Indianapolis, Indiana, United States
Louisville
Louisville, Kentucky, United States
Raynham
Raynham, Massachusetts, United States
Las Vegas
Las Vegas, Nevada, United States
Raleigh
Raleigh, North Carolina, United States
...and 12 more locations
Time frame: 14 Days [Visit 1 (baseline) and Visit 3 (14 days)]
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1
Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.
Time frame: 7 Days [Visit 1 (baseline) and Visit 2 (7 days)]