NCT05045508

Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Photorefractive Keratectomy (PRK)

A Randomized, Controlled, Double-Masked, Two-Arm Investigator-Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Photorefractive Keratectomy (PRK)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Brandon Baartman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray among subjects suffering from dry eye following photorefractive keratectomy (PRK)

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	OC-01 (varenicline 0.6mg/ml) nasal spray	OC-01 nasal spray which contains varenicline is being developed by Oyster Point Pharma for the treatment of signs and symptoms of DED. OC-01 (varenicline) nasal spray activates the trigeminal parasympathetic pathway and stimulates natural tear production and bathe the corneal nerve endings in a protective layer of tear film. In addition, OC-01 (varenicline) acts as a cholinergic agonist and may provide analgesia by activating the trigeminal parasympathetic pathway.
DRUG	Placebo (vehicle) Nasal Spray	Placebo (vehicle) nasal spray \[control\]

Timeline

• Start date: 2021-08-30
• Primary completion: 2022-08-30
• Completion: 2023-01-30
• First posted: 2021-09-16
• Last updated: 2021-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study