Dry Eye Disease
Conditions
Keywords
OC-01, Dry Eye Disease
Brief summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline solution) Nasal Spray as compared to placebo (vehicle) on signs and symptoms of dry eye disease.
Interventions
Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days
Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days
Sponsors
Oyster Point Pharma, Inc.
Corxel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
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 12 months of the Screening Visit * 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, acute 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 (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 investigational product 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer's Test Score | 28 days | Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from Baseline in Schirmer's Test Score (STS) | 28 days | Schirmer's test scores are from 0-35 mm where a higher score is indicative of a better outcome. |
| Mean change from Baseline in Eye Dryness Score (EDS) | 28 days/ 14 days/ 7days | Eye dryness score is assessed on a visual analogue scale with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome |
Other
| Measure | Time frame |
|---|---|
| Mean change from Baseline in Temporal Corneal Fluorescein Staining | 28 days |
| Mean change from Baseline in Total Corneal Fluorescein Staining | 28 days |
| Mean change from Baseline in Superior Corneal Fluorescein Staining | 28 days |
| Mean change from Baseline in Central Corneal Fluorescein Staining | 28 days |
| Mean change from Baseline in Inferior Corneal Fluorescein Staining | 28 days |
| Mean change from Baseline in Nasal Corneal Fluorescein Staining | 28 days |
Countries
China
Outcome results
None listed