NCT04957758

Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy

A Phase 2, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray in Subjects With Neurotrophic Keratopathy (the Olympia Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Oyster Point Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for mean change from baseline in corneal fluorescein staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.

Detailed description

Protocol OPP-102 is a Phase 2, multicenter, randomized, controlled, double- masked study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with NK. Approximately 100 subjects at least 18 years of age with a physicians' diagnosis of Stage 1 NK as defined by the Mackie Criteria and meeting all other study eligibility criteria will be randomized 1:1 and will receive OC-01 (varenicline)/ nasal spray or placebo nasal spray for 8 weeks three times daily (TID) as follows: * OC-01 (varenicline) nasal spray, 1.2 mg/mL * Placebo (vehicle control) nasal spray All doses will be delivered as a 50 microliter (µL) nasal spray.

Conditions

• Neurotrophic Keratopathy

Interventions

Type	Name	Description
DRUG	OC-01 (varenicline) nasal spray 1.2 mg/ml	OC-01
DRUG	Placebo (vehicle) nasal spray	Placebo (vehicle)

Timeline

• Start date: 2021-06-17
• Primary completion: 2023-01-27
• Completion: 2023-04-28
• First posted: 2021-07-12
• Last updated: 2024-05-07
• Results posted: 2024-05-07

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study