Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)

Dry Eye Disease Clinical Trial

Official title:

Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633461
• Other study ID #: OPP-003
• Status: Completed
• Phase: Phase 2
• Start date: August 14, 2018
• Est. completion date: September 20, 2018

Study information

• Verified date: February 2022
• Source: Oyster Point Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and effectiveness of OC-02 nasal spray compared to placebo on signs and symptoms of dry eye disease (DED).

Description:

This was a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-02 Nasal Spray in adult subjects with dry eye disease. Approximately 45 subjects, at least 22 years of age, with a history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of OC-02 or placebo twice daily (BID) for 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 20, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 60 days 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 epithelial keratomileusis, laser-assisted in-situ keratomileusis, photorefractive keratectomy or corneal implant) 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 dry eye disease 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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• OC-02 (simpinicline) nasal spray
OC-02 (simpinicline) nasal spray, 11.1 mg/ml
• Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray

Locations

Country	Name	City	State
United States	Louisville	Louisville	Kentucky
United States	Nashville	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Oyster Point Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Schirmer's Test From Baseline to 28 Days	The primary end point was the change in anesthetized Schirmer's Test Score (STS) from baseline to 28 days in the study eye following treatment with OC-02. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.	28 days [Visit 1 (baseline) and Visit 5 (28 Days)]