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

NCT03633461 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OPP-003
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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)]

Study Arms (2)

OC-02 (simpinicline) spray spray, 11.1 mg/ml

ACTIVE COMPARATOR

OC-02 (simpinicline) nasal spray, 11.1 mg/ml

Drug: OC-02 (simpinicline) nasal spray

Placebo

PLACEBO COMPARATOR

Placebo (vehicle) nasal spray

Drug: Placebo (vehicle) nasal spray

Interventions

OC-02 (simpinicline) nasal spray DRUG

OC-02 (simpinicline) nasal spray, 11.1 mg/ml

Also known as: OC-02 (simpinicline) nasal spray, 11.1 mg/ml

OC-02 (simpinicline) spray spray, 11.1 mg/ml

Placebo (vehicle) nasal spray DRUG

Placebo (vehicle) nasal spray

Placebo

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 60 days prior to Visit 1

You may not qualify if:

• 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

Sponsors & Collaborators

• Oyster Point Pharma, Inc.: lead

Study Sites (2)

Louisville

Louisville, Kentucky, 40206, United States

Location

Nashville

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Nasal Sprays

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Jeffery Nau
• Organization: Oyster Point Pharma, Inc.

jnau@oysterpointrx.com

609-382-9035

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: August 14, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: March 9, 2022
• Results First Posted: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)