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

Dry Eye Disease (DED) Clinical Trial

Official title:

Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036292
• Other study ID #: OPP-101
• Status: Completed
• Phase: Phase 3
• Start date: July 23, 2019
• Est. completion date: February 5, 2021

Study information

• Verified date: August 2021
• Source: Oyster Point Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 758
• Est. completion date: February 5, 2021
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease (DED)
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Oyster Point Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Secondary	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.	28 Days [Visit 1 (baseline) and Visit 4a (28 days)]
Secondary	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.	28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Secondary	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.	28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Secondary	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.	14 Days [Visit 1 (baseline) and Visit 3 (14 days)]
Secondary	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.	7 Days [Visit 1 (baseline) and Visit 2 (7 days)]