NCT03688802

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (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 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.

Detailed 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

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray
DRUG	Placebo (vehicle control) nasal spray	Placebo

Timeline

• Start date: 2018-09-25
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2018-09-28
• Last updated: 2021-12-29
• Results posted: 2021-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study