Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: OC-01 (varenicline) nasal spray; Drug: Placebo (vehicle) nasal spray

• Registration Number: NCT03636061
• Lead Sponsor: Oyster Point Pharma, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2018-08-15
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Primary Completion: 2018-09-26
• Study Completion: 2018-09-26
• Disposition First Submitted: 2019-05-14
• Status Verified: 2021-08
• Results First Submitted: 2021-08-13
• Results First Submitted QC: 2021-10-21
• Disposition First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Results First Posted: 2021-10-25
• Disposition First Posted: 2021-10-25
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1

Exclusion Criteria

• Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of Visit 1
• Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
• Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
• Have a known hypersensitivity to any of the procedural agents or study drug components
• Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OC-01 Mid Dose, 0.6 mg/mL	OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray Mid dose, 0.6 mg/mL
Placebo	Placebo (vehicle) nasal spray	Placebo (vehicle) nasal spray
OC-01 Low Dose, 0.12 mg/mL	OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray, Low Dose, 0.12 mg/mL
OC-01 High Dose, 1.2 mg/mL	OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray High dose, 1.2 mg/mL

Primary Outcome Measures

Name	Time	Method
Mean Change in Schirmer's Test Score From Baseline to 28 Days	28 Days [Visit 1 (baseline) and Visit 5 (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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Eye Dryness Score From Baseline to Day 28	28 days [Visit 1 (baseline and Visit 5 (28 days)]	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.
Change From Baseline to Day 21 in Eye Dryness Score at 5 Minutes Post Treatment in the CAE.	21 days [Visit 1 (baseline) and Visit 4 (21 days)]	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.

Trial Locations

Locations (3)

Newport Beach; 🇺🇸 Newport Beach, California, United States

Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

Andover; 🇺🇸 Andover, Massachusetts, United States