Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy (“PRK”)
Overview
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).
Full Title of Study: “A Randomized Masked (Reading Center), Controlled, Prospective Pivotal Study of the Effectiveness and Safety of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid (HA) Applied Topically, Versus a Bandage Contact Lens (BCL) in Accelerating Re-epithelialization of Large Corneal Epithelial Defects in Patients Having Undergone Photorefractive Keratectomy (PRK).”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: October 1, 2019
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.
Interventions
- Device: Ocular Bandage Gel (OBG)
- A modified form of the natural polymer hyaluronic acid, which is a gel that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries including surgical trauma.
- Device: Bandage Contact Lens (BCL)
- A bandage contact lens protects an injured or diseased cornea from the mechanical rubbing of the blinking eyelids, therefore allowing it to heal. It is a normal (usually soft, but not always) contact lens has no power. It is not intended to improve your vision.
Arms, Groups and Cohorts
- Experimental: 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.
- Other: 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.
Clinical Trial Outcome Measures
Primary Measures
- Complete corneal re-epithelialization on Day 3
- Time Frame: 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 Measures
- Time to corneal re-epithelialization
- Time Frame: 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.
Participating in This Clinical Trial
Inclusion Criteria
- Undergone PRK with a fresh epithelial defect. – Best corrected visual acuity (BCVA) of 20/20 or better at baseline Exclusion Criteria:
- 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.
Gender Eligibility: All
Minimum Age: 22 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Eyegate Pharmaceuticals, Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Barbara Wirostko, M.D., Study Director, EyeGate
References
Durrie DS, Wolsey D, Thompson V, Assang C, Mann B, Wirostko B. Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy. J Cataract Refract Surg. 2018 Mar;44(3):369-375. doi: 10.1016/j.jcrs.2018.01.018.
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