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

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Oyster Point Pharma, Inc.
Updated on 6 December 2022
Investigator
Marian Macsai
Primary Contact
Littleton, Colorado (1.8 mi away) Contact
+27 other location

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.

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.

Details
Condition Neurotrophic Keratopathy
Treatment OC-01 (varenicline) nasal spray 1.2 mg/ml, Placebo (vehicle) nasal spray
Clinical Study IdentifierNCT04957758
SponsorOyster Point Pharma, Inc.
Last Modified on6 December 2022

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