NCT03873246

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Oyster Point Pharma, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	OC-01 0.1% 0.6 mg/ml	OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)
DRUG	OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)	OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)
OTHER	placebo comparator	vehicle control

Timeline

• Start date: 2019-02-18
• Primary completion: 2020-01-07
• Completion: 2020-01-07
• First posted: 2019-03-13
• Last updated: 2022-06-08
• Results posted: 2022-06-08

Locations

1 site across 1 country: Mexico