NCT03633461

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Oyster Point Pharma, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	OC-02 (simpinicline) nasal spray	OC-02 (simpinicline) nasal spray, 11.1 mg/ml
DRUG	Placebo (vehicle) nasal spray	Placebo (vehicle) nasal spray

Timeline

• Start date: 2018-08-14
• Primary completion: 2018-09-20
• Completion: 2018-09-20
• First posted: 2018-08-16
• Last updated: 2022-03-09
• Results posted: 2022-02-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study