Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)

Dry Eye Disease Clinical Trial

Official title: Randomized, Controlled, Single-Masked Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)

Status Completed

Clinical Trial Summary

The objective of this study is to evaluate the chronic safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs of dry eye disease (DED).

Clinical Trial Description

Study OPP-004 was a Phase 2, single-center, randomized, masked (including subjects, Investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in adult subjects with DED. The study planned to randomize approximately 120 subjects at least 22 years of age with a physicians' diagnosis of Dry Eye Disease and meeting all other study eligibility criteria to receive an application of OC-01 or placebo BID for 12 weeks. Subjects who terminated early during the application period were asked to complete safety assessments (if the subjects agree) prior to study exit. Subjects who were terminated early from the study were not replaced. ;

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

• NCT number: NCT03873246
• Study type: Interventional
• Source: Oyster Point Pharma, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: February 18, 2019
• Completion date: January 7, 2020