NCT03920215

Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET Study)-Long Term Safety Follow-up

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Oyster Point Pharma, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).

Detailed description

Study OPP-002-01 was a long-term follow-up study of those subjects who had previously participated in the OPP-002 study (NCT03636061). The OPP-002 study is a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-01 nasal spray in adult participants with dry eye disease. The first scheduled visit occurs 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study. The second scheduled visit occurs 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.

Conditions

• Long Term Follow up Dry Eye Disease

Interventions

Type	Name	Description
DRUG	OC-01 Low Dose, 0.12 mg/mL	OC-01 (varenicline) nasal spray
DRUG	OC-01 Mid Dose, 0.6 mg/mL	OC-01 (varenicline) nasal spray
DRUG	OC-01 High Dose, 1.2 mg/mL	OC-01 (varenicline) nasal spray
DRUG	Placebo (vehicle) nasal spray	Placebo (vehicle) nasal spray

Timeline

• Start date: 2018-08-15
• Primary completion: 2019-09-20
• Completion: 2019-09-20
• First posted: 2019-04-18
• Last updated: 2023-11-01
• Results posted: 2021-11-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study