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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. ;


Study Design


Related Conditions & MeSH terms


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

See also
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Terminated NCT03084861 - A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy Phase 1/Phase 2
Active, not recruiting NCT06411145 - Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis Phase 4
Recruiting NCT05555589 - Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2 Phase 3
Not yet recruiting NCT06331910 - Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers Phase 4