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)
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
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
Placebo (vehicle) nasal spray
Vance Thompson Vision-MT
Bozeman, Montana, United States
NEI VFQ-25 Questionnaire
questionnaire assesses effect of visual impairment on the patient's current health-related quality of life, including questions dealing with irritation in and around the eye. The score on a scale is from 0 to 100 points. A score of 0 is the worst score and a score of 100 is the best score and means the patient has no vision problems
Time frame: from baseline to Day 28 (1-month postoperative CXL)
Corneal Epithelial Healing
Corneal epithelial healing rate at days 2 (48 hours), 3 (72 hours), 4 (96 hours) after creation of 9mm epithelial defect as measured by a masked physician
Time frame: Up to 96 hours after creation of 9mm epithelial defect
Dryness Scoring
Mean change in eye dryness score (EDS) as measured by the Visual Analogue Scale (VAS) from baseline over time to Day 28 (1 month postoperatively CXL) as measured by masked evaluator
Time frame: from baseline over time to Day 28 (1 month postoperatively CXL)
Corneal Fluorescein Staining
Mean change in corneal fluorescein staining from baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL) as evaluated by masked physician
Time frame: from baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL)
Tear Break Up Time
Mean change in tear break up time (TBUT) from baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL)
Time frame: baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL)
Adverse Events
Incidence and severity of adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 56 days (4 weeks preop and 4 weeks postop)