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

Neurotrophic Keratopathy Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neurotrophic Keratopathy

• NCT number: NCT04957758
• Study type: Interventional
• Source: Oyster Point Pharma, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: June 17, 2021
• Completion date: April 28, 2023