Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy ("PRK")

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).

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 Overview

• Status: Completed
• Conditions: Refractive Surgery; Ophthalmology; Photorefractive Keratectomy ("PRK"); Laser Assisted Surgery
• Intervention / Treatment: Device: Ocular Bandage Gel (OBG); Device: Bandage Contact Lens (BCL)

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: crosslinked thiolated carboxymethyl hyaluronic acid ("CMHA-S")
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.	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.; Other Names: Acuvue Oasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete corneal re-epithelialization on Day 3	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.	Day 3 (72 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to corneal re-epithelialization	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.	Day 3 (72 hours)

Collaborators and Investigators

• Sponsor: Eyegate Pharmaceuticals, Inc.
• Investigators: Study Director: Barbara Wirostko, M.D., EyeGate

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Photorefractive Keratectomy, Corneal Defect
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: EYEGATE-034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan developed or decided upon at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes