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

Refractive Surgery Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938883
• Other study ID #: EYEGATE-034
• Status: Completed
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: October 10, 2019

Study information

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

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 10, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laser Assisted Surgery
• Ophthalmology
• Photorefractive Keratectomy (PRK)
• Refractive Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Vance Thompson Vision	Sioux Falls	South Dakota

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.jcrs.2018.01.018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)