NCT05136924

IIT Assessing OC-01Nasal Spray on Symptoms of DED Following CXL

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 Corneal Collagen Crosslinking (CXL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vance Thompson Vision - MT · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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 Corneal Collagen Crosslinking (CXL)

Detailed description

Rationale for Study Design This study is a single center, prospective, randomized, controlled, double-masked, two-arm investigator-initiated study to investigate the efficacy of OC-01 on signs and symptoms of dry eye disease in subjects following corneal collagen crosslinking (CXL). 2\. STUDY OBJECTIVES 2.1 Primary Objective * Mean change in NEI VFQ-25 from baseline to Day 0, Day 7, and Day 28 (1-month postoperative CXL) * Coneal epithelial healing rate at days 2 (48 hours), 3 (72 hours), 4 (96 hours) after creation of 9 mm corneal epithelial defect as evaluated by masked physician 2.2 Secondary Objectives * Mean change in eye dryness score (EDS) as measured by the Visual Analogue Scale (VAS) from baseline overtime to Day 28 (1 month postoperatively CXL) as measured by masked evaluator * Mean change in corneal fluorescein staining from baseline to Day 0 (surgical day) and Day 0 to Day 28 (1-month postoperative CXL) as evaluated by masked physician * Mean change in tear break up time (TBUT) from baseline to Day 0 (surgical day) and day 0 to day 28 (1-month postoperative CXL) * Incidence and severity of adverse events

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	OC-01 (varenicline 1.2mg/ml) nasal spray vs Placebo	OC-01 nasal spray containing varenicline for treatment of signs and symptoms of DED. 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 VS Placebo
OTHER	Placebo (vehicle) nasal spray	Placebo (vehicle) nasal spray

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-11-30
• Last updated: 2021-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study