NCT04036292

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

Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 758 (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 3, multicenter, randomized, controlled, double-masked (including subjects, Investigators, study site personnel, and Sponsor personnel) study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray 0.6 mg/mL and 1.2 mg/mL in adult participants with DED. The study randomized 758 subjects at least 22 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria to receive OC-01 (varenicline) nasal spray or placebo twice daily (BID) for 28 days with three additional long-term follow-up visits at 6 weeks, 6 months, and 12 months. Participants who terminated from the study during the treatment period were asked to complete safety assessments (if the participants agree) prior to study exit. Participants who were terminated early from the study were not replaced

Conditions

• Dry Eye Disease (DED)

Interventions

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

Timeline

• Start date: 2019-07-23
• Primary completion: 2020-04-10
• Completion: 2021-02-05
• First posted: 2019-07-29
• Last updated: 2021-11-22
• Results posted: 2021-11-22

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study