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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
Placebo (vehicle) nasal spray \[control\]
Vance Thompson Vision ND
West Fargo, North Dakota, United States
Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score
25 questions to determine overall score of dry eye disease symptoms completed by subject. Scored from 0-100, with 100 being the highest score and best outcome.
Time frame: Baseline to Day 84 (3 months)
Mean change in corneal fluorescein staining based on the NEI (National Eye Institute) scale for Corneal Fluorescein Staining determined at slit lamp
Evaluated at slit lamp by a masked physician
Time frame: Baseline to Surgical Day and from Surgical Day to Day 84 (3-month)
Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score
25 questions to determine overall score of dry eye disease symptoms completed by subject. Scored from 0-100, with 100 being the highest score and best outcome.
Time frame: Baseline to Day 184 (6 months)
Mean change in eye dryness score (EDS)
Eye dryness score (EDS) measured by the Visual Analogue Scale (VAS). Scored from 0-100, with 100 being the worst pain imaginable, and zero no pain.
Time frame: Baseline to Day 184 (6 months)
Mean change in residual refractive error
Evaluated by manifest refraction
Time frame: Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month) postoperative LASIK
Change in tear collection lab values
As determined by Schirmer's strips
Time frame: Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month)
Mean change tear break-up time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
As determined by tear break-up testing
Time frame: baseline to Day 0 (Surgical Day), Day 28 (1-month) postoperative LASIK and Day 84 (3-month) postoperative LASIK
Proportion of subjects treated with rescue dry treatment and/or punctal plugs
Determined at follow up appointment by Doctor
Time frame: Day 84 (3-months) postoperative and Day 168 (6-months) postoperative LASIK
Incidence and severity of adverse events
As reported by study coordinators and evaluated by PI
Time frame: Screening to Day 168 (6-month postoperative LASIK)