Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy ("PRK")
- Conditions
- OphthalmologyRefractive SurgeryPhotorefractive Keratectomy ("PRK")Laser Assisted Surgery
- Interventions
- Device: Bandage Contact Lens (BCL)Device: Ocular Bandage Gel (OBG)
- Registration Number
- NCT03938883
- Lead Sponsor
- Eyegate Pharmaceuticals, Inc.
- Brief Summary
Prospective, randomized, masked (reading center), controlled pivotal study of Ocular Bandage Gel (OBG) vs. a bandage contact lens (BCL) in subjects who have undergone bilateral photorefractive keratectomy (PRK).
- Detailed Description
This is a prospective, randomized, masked (reading center), controlled pivotal study of Ocular Bandage Gel (OBG) vs. a Bandage Contact Lens (BCL) in subjects who have undergone bilateral photorefractive keratectomy (PRK).
Study subjects will be evaluated and, if eligible following PRK, will receive the study treatment in a 1:1 randomization with both eyes receiving the same treatment.
Sites will capture the time that PRK surgery OU is completed. Sites will enroll eligible subjects and randomly assign a subject to Treatment Group (OBG) or Control Group (BCL). One eye will be randomized as the designated "study eye" for statistical purposes.
The reading center will be masked as to the randomization assignments. Both eyes will receive the same randomized assignment and both eyes of each subject will be evaluated at all timepoints.
The defect in both eyes of all subjects will be measured starting at Day 2 (48 hours after PRK). The slit lamp photos are to be collected at 48 hours (±1 hour) from PRK completion in both eyes.
The BCL in the Control Group eyes will be removed daily starting at Day 2 for slit lamp photos. Slit lamp measurements, as well as photography of the epithelial defect (without and with fluorescein), will be taken of both eyes of all subjects. Photos will be evaluated by a masked reading center.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Undergone PRK with a fresh epithelial defect.
- Best corrected visual acuity (BCVA) of 20/20 or better at baseline
- History of systemic disorders that may affect post-operative healing.
- Corneal pathology that would affect wound re-epithelization.
- Use of medications that may affect the rate of corneal healing.
- Pregnant or lactating females.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bandage Contact Lens (BCL) Bandage Contact Lens (BCL) standard-of-care post-operative intervention following PRK. BCL (Acuvue® Oasys plano lens) applied OU. Bandage contact lens use is discontinued once complete re-epithelialization has occurred in that eye. Ocular Bandage Gel (OBG) Ocular Bandage Gel (OBG) Cross-linked Hyaluronic Acid 0.75%, regulated through CDRH (device). EyeGate Ocular Bandage Gel will be applied topically to both eyes (OU) four times a day. Ocular Bandage Gel use is discontinued once complete re-epithelialization has occurred in that eye.
- Primary Outcome Measures
Name Time Method Complete corneal re-epithelialization on Day 3 Day 3 (72 hours) Evaluated by a masked reading center using digital photography of fluorescein stained slit lamp photos and image analysis. Proportion of eyes following PRK surgery with complete corneal re-epithelization of the epithelial defect on Day 3 and no recurrent erosions.
- Secondary Outcome Measures
Name Time Method Time to corneal re-epithelialization Day 3 (72 hours) Evaluated by a masked reading center using digital photography of fluorescein stained slit lamp photos and image analysis. Time to closure in eyes following PRK surgery with complete re-epithelialization and no recurrent erosions.
Trial Locations
- Locations (1)
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States