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

EyeGate Pharmaceuticals

Status: Completed

Conditions: Laser Assisted Surgery; Photorefractive Keratectomy ("PRK"); Ophthalmology; Refractive Surgery

Treatments: Device: Bandage Contact Lens (BCL); Device: Ocular Bandage Gel (OBG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03938883

EYEGATE-034

Details and patient eligibility

About

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 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.

Enrollment: 250 patients

Sex: All

Ages: 22 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Ocular Bandage Gel (OBG)

Experimental group

Description:

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.

Treatment:

Device: Ocular Bandage Gel (OBG)

Bandage Contact Lens (BCL)

Other group

Description:

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.

Treatment:

Device: Bandage Contact Lens (BCL)