NCT03636061

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

Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-1 Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (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-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease

Detailed 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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray
DRUG	Placebo (vehicle) nasal spray	Placebo

Timeline

• Start date: 2018-08-15
• Primary completion: 2018-09-26
• Completion: 2018-09-26
• First posted: 2018-08-17
• Last updated: 2021-10-25
• Results posted: 2021-10-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study