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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2020-01-07

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).

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OC-01 0.1%, 0.6 mg/ml

OC-01 (varenicline) nasal spray, 0.6 mg/mL

Group Type ACTIVE_COMPARATOR

OC-01 0.1% 0.6 mg/ml

Intervention Type DRUG

OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)

OC-01 0.2%, 1.2 mg/ml

OC-01 (varenicline) nasal spray, 1.2 mg/mL

Group Type ACTIVE_COMPARATOR

OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)

Intervention Type DRUG

OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)

Placebo

vehicle control

Group Type PLACEBO_COMPARATOR

placebo comparator

Intervention Type OTHER

vehicle control

Interventions

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OC-01 0.1% 0.6 mg/ml

OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)

Intervention Type DRUG

OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)

Intervention Type DRUG

placebo comparator

vehicle control

Intervention Type OTHER

Other Intervention Names

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varenicline varenicline

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No