Randomized, Controlled, Single-Masked Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)
Overview
- Phase
- Phase 2
- Intervention
- OC-01 0.1% 0.6 mg/ml
- Conditions
- Dry Eye Disease
- Sponsor
- Oyster Point Pharma, Inc.
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- Mean Change in Schirmer's Test Score From Baseline to 84 Days
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of this study is to evaluate the chronic safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs of dry eye disease (DED).
Detailed Description
Study OPP-004 was a Phase 2, single-center, randomized, masked (including subjects, Investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in adult subjects with DED. The study planned to randomize approximately 120 subjects at least 22 years of age with a physicians' diagnosis of Dry Eye Disease and meeting all other study eligibility criteria to receive an application of OC-01 or placebo BID for 12 weeks. Subjects who terminated early during the application period were asked to complete safety assessments (if the subjects agree) prior to study exit. Subjects who were terminated early from the study were not replaced.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have used and/or desired to us 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 (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 an 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
Arms & Interventions
OC-01 0.1%, 0.6 mg/ml
OC-01 (varenicline) nasal spray, 0.6 mg/mL
Intervention: OC-01 0.1% 0.6 mg/ml
Placebo
vehicle control
Intervention: placebo comparator
Outcomes
Primary Outcomes
Mean Change in Schirmer's Test Score From Baseline to 84 Days
Time Frame: Visit 1 (baseline) and Visit 6 (84 days)
The Schirmer's test measures the amount of tears produced by numbing the eye and placing a paper strip in the eye for 5 minutes and distance of wetting was recorded following treatment with OC-01 or placebo. Schirmer's test scores range from 0-35 mm where a higher score is indicative of a better outcome.