Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy ("PRK")
Condition: Ophthalmology; Photorefractive Keratectomy ("PRK"); Laser Assisted Surgery; Refractive Surgery
Study type: Interventional

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).
    

Detailed 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.
    

Intervention name(s): Ocular Bandage Gel (OBG); Bandage Contact Lens (BCL)
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Other intervention name(s): crosslinked thiolated carboxymethyl hyaluronic acid ("CMHA-S"); Acuvue Oasys
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects (all eyes) who receive any study treatment will be evaluable for safety analysis. All treatment assignments are assigned through 1:1 randomization with one eye designated as the "study eye" for statistical purposes. The final subject evaluability will be determined prior to breaking the code for masked treatment assignment and locking the database.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Photorefractive Keratectomy, Corneal Defect