Safety and Effectiveness of OBG vs.a Bandage Contact Lens for Large Corneal Epithelial Defects in Patients Post-PRK.

• Sponsor: Eyegate Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03163641
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 14.4

Study Details

Study Description

Brief Summary

This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area.

Condition or Disease	Intervention/Treatment	Phase
Corneal Epithelial Wound	Device: Acuvue Oasys; Device: Ocular Bandage Gel	N/A

Detailed Description

This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area. Subjects will be assigned to one of three treatment arms on Day 0.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Used a masked reading center to review the corneal defect staining.
• Primary Purpose: Treatment
• Official Title: A Randomized, Masked (Reading Center), Prospective Pilot Study of the Safety and Effectiveness of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid Applied Topically, Versus a Bandage Contact Lens for Acceleration of Re-epithelialization of Large Corneal Epithelial Defects in Patients Having Undergone Photorefractive Keratectomy (PRK).
• Actual Study Start Date: Aug 5, 2018
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Nov 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 1 Ocular Bandage Gel	Device: Ocular Bandage Gel; 0.75% crosslinked HA
Experimental: Treatment 2 Ocular Bandage Gel	Device: Ocular Bandage Gel; 0.75% crosslinked HA
Active Comparator: Control Group Artificial tears with Acuvue Oasys	Device: Acuvue Oasys; Bandage Contact Lens; Device: Ocular Bandage Gel; 0.75% crosslinked HA

Outcome Measures

Primary Outcome Measures

1. Time to corneal re-epithelization post PRK [Day 3]

   Time to corneal re-epithelization post PRK

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able and willing to comply with the protocol

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Houston, Texas	Houston	Texas	United States	77077

Sponsors and Collaborators

• Eyegate Pharmaceuticals, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eyegate Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03163641
• Other Study ID Numbers: EYEGATE-033
• First Posted: May 23, 2017
• Last Update Posted: Dec 17, 2020
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Eyegate Pharmaceuticals, Inc.: Photorefractive Keratectomy, Corneal Defect

Study Results

No Results Posted as of Dec 17, 2020