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

Corneal Epithelial Wound Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163641
• Other study ID #: EYEGATE-033
• Status: Completed
• Phase: N/A
• Start date: August 5, 2018
• Est. completion date: November 8, 2018

Study information

• Verified date: January 2019
• Source: Eyegate Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 8, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 50 Years

Eligibility

Inclusion Criteria:

• Able and willing to comply with the protocol

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Corneal Epithelial Wound

Intervention

Device:
• Acuvue Oasys
Bandage Contact Lens
• Ocular Bandage Gel
0.75% crosslinked HA

Locations

Country	Name	City	State
United States	Houston, Texas	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eyegate Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.jcr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to corneal re-epithelization post PRK	Time to corneal re-epithelization post PRK	Day 3