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

Phase 3

Completed

Conditions: Dry Eye Disease (DED)

Interventions: Drug: OC-01 (varenicline) nasal spray
Drug: Placebo (vehicle) nasal spray

Registration Number: NCT04036292

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 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 758

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) or extraocular surgery in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) 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 dry eye disease 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 High Dose, 1.2 mg/mL	OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray, 1.2 mg/ML
Placebo (vehicle) nasal spray	Placebo (vehicle) nasal spray	Placebo (vehicle) nasal spray
OC-01 Low Dose, 0.6 mg/mL	OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray, 0.6 mg/ML

Primary Outcome Measures

Name	Time	Method
Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)	28 Days [Visit 1 (baseline) and Visit 4b (28 days)]	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2	14 Days [Visit 1 (baseline) and Visit 3 (14 days)]	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.
Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28	28 Days [Visit 1 (baseline) and Visit 4b (28 days)]	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.
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1	7 Days [Visit 1 (baseline) and Visit 2 (7 days)]	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.
Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28	28 Days [Visit 1 (baseline) and Visit 4b (28 days)]	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.
Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes	28 Days [Visit 1 (baseline) and Visit 4a (28 days)]	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.

Trial Locations

Locations (21): Delray Beach
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Delray Beach, Florida, United States
San Antonio
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San Antonio, Texas, United States
Lynchburg
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Lynchburg, Virginia, United States
Austin
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Austin, Texas, United States
Nashville
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Nashville, Tennessee, United States
Indianapolis
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Indianapolis, Indiana, United States
Houston
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Houston, Texas, United States
New Port Beach
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Newport Beach, California, United States
Fort Collins
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Fort Collins, Colorado, United States
Las Vegas
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Las Vegas, Nevada, United States
Raleigh
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Raleigh, North Carolina, United States
Shelby
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Shelby, North Carolina, United States
Fargo
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Fargo, North Dakota, United States
Warwick
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Warwick, Rhode Island, United States
Cranberry Township
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Cranberry Township, Pennsylvania, United States
Layton
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Layton, Utah, United States
Sioux Falls
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Sioux Falls, South Dakota, United States
Phoenix
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Phoenix, Arizona, United States
Waterbury
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Waterbury, Connecticut, United States
Raynham
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Raynham, Massachusetts, United States
Louisville
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Louisville, Kentucky, United States