NCT05082974View on ClinicalTrials.gov

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)

PHASE3CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 20, 2021

Primary Completion Date

August 3, 2022

Study Completion Date

August 3, 2022

Conditions
Dry Eye Disease
Interventions
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 \[control\]

Trial Locations (1)

58078

Vance Thompson Vision ND, West Fargo

All Listed Sponsors
lead

Vance Thompson Vision ND

OTHER

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) | Biotech Hunter | Biotech Hunter