Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: OC-01 0.1% 0.6 mg/ml
* Drug: OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)
* Other: placebo comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OC-01 0.1%, 0.6 mg/ml<br>OC-01 (varenicline) nasal spray, 0.6 mg/mL | Drug: OC-01 0.1% 0.6 mg/ml<br>* OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)<br>* Other names: varenicline;|
| Active Comparator: OC-01 0.2%, 1.2 mg/ml<br>OC-01 (varenicline) nasal spray, 1.2 mg/mL | Drug: OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)<br>* OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)<br>* Other names: varenicline;|
| Placebo Comparator: Placebo<br>vehicle control | Other: placebo comparator<br>* vehicle control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Schirmer's Test Score From Baseline to 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. | Visit 1 (baseline) and Visit 6 (84 days) |