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

EyeGate Pharmaceuticals

Status: Completed

Conditions: Corneal Epithelial Wound

Treatments: Device: Ocular Bandage Gel; Device: Acuvue Oasys

Study type: Interventional

Funder types: Industry

Identifiers

NCT03163641

EYEGATE-033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 22 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able and willing to comply with the protocol

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Treatment 1

Experimental group

Description:

Ocular Bandage Gel

Treatment:

Device: Ocular Bandage Gel

Treatment 2

Experimental group

Description:

Ocular Bandage Gel

Treatment:

Device: Ocular Bandage Gel

Control Group

Active Comparator group

Description:

Artificial tears with Acuvue Oasys

Treatment:

Device: Acuvue Oasys

Device: Ocular Bandage Gel