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).
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).
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.
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