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Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation

Dry Eye Disease Clinical Trial

Official title:
A Single-Center, Randomized, Controlled, Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation (The IMPERIAL Study)

Clinical Trial Summary

The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.

Clinical Trial Description

This was a Phase 2, single-center, randomized, masked (including all subjects, investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in stimulating goblet cell and Meibomian gland function in in adult subjects with DED. Approximately 45 subjects at least 18 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria were planned to be randomized to receive a single application of 0.2% (1.2 mg/mL) OC-01 or placebo ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03688802
Study type Interventional
Source Oyster Point Pharma, Inc.
Contact
Status Completed
Phase Phase 2
Start date September 25, 2018
Completion date September 30, 2019
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