NCT05082974

Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK)

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 in Subjects Following Laser-assisted in Situ Keratomileusis (LASIK)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Vance Thompson Vision ND · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray for amelioration of signs and symptoms of dry eye disease in subjects following laser-assisted in situ keratomileusis (LASIK).

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	OC-01 (varenicline 0.6mg/ml) nasal spray	OC-01 (varenicline 0.6mg/ml) nasal spray which contains varenicline is being developed by Oyster Point Pharma for the treatment of signs and symptoms of Drye Eye Disease. OC-01 (varenicline) nasal spray activates the trigeminal parasympathetic pathway and stimulates natural tear production to 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: 2021-10-20
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2021-10-19
• Last updated: 2023-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study