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

Oyster Point Pharma

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: OC-01 (varenicline) nasal spray; Drug: Placebo (vehicle) nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT03636061

OPP-002

Details and patient eligibility

About

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

Full description

This was a Phase 2b, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 01 nasal spray in adult subjects with DED. The study randomized 182 subjects, at least 22 years of age, who had a physician's diagnosis of dry eye disease and met all other study eligibility criteria to receive an application of OC-01 or placebo twice daily (BID) for 4 weeks.

Enrollment: 182 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 4 patient groups, including a placebo group

OC-01 Low Dose, 0.12 mg/mL

Active Comparator group

Description:

OC-01 (varenicline) nasal spray, Low Dose, 0.12 mg/mL

Treatment:

Drug: OC-01 (varenicline) nasal spray

OC-01 Mid Dose, 0.6 mg/mL

Active Comparator group

Description:

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

Treatment:

Drug: OC-01 (varenicline) nasal spray

OC-01 High Dose, 1.2 mg/mL

Active Comparator group

Description:

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

Treatment:

Drug: OC-01 (varenicline) nasal spray

Placebo

Placebo Comparator group

Description:

Placebo (vehicle) nasal spray

Treatment:

Drug: Placebo (vehicle) nasal spray