Phase 3 N=758 Randomized Double-blind Treatment

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

Dry Eye Disease (DED)

Bottom Line

View on ClinicalTrials.gov: NCT04036292 ↗

Enrolled (actual)

758

Serious AEs

3.4%

Results posted

Nov 2021

Primary outcome: Primary: Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28) — 123; 121; 70 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: OC-01 (varenicline) nasal spray (Drug); Placebo (vehicle) nasal spray (Drug)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Oyster Point Pharma, Inc.
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)	123; 121; 70	—
SECONDARY Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes	-10.3; -9.0; -7.4	—
SECONDARY Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28	-19.8; -22.2; -15.4	—
SECONDARY Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28	11.3; 11.5; 6.3	—
SECONDARY Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2	-16.5; -17.9; -12.7	—
SECONDARY Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1	-15.7; -15.4; -13.3	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04036292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.