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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

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

Clinicaltrials.gov identifier NCT03938883

Recruitment Status Completed

First Posted May 6, 2019

Last update posted December 13, 2019

Study Description

Brief 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).

  • Condition or Disease:Ophthalmology
    Photorefractive Keratectomy ("PRK")
    Laser Assisted Surgery
    Refractive Surgery
  • Intervention/Treatment: Device: Ocular Bandage Gel (OBG)
    Device: Bandage Contact Lens (BCL)
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 250 participants
  • 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
  • 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).
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: October 2019
  • Actual Study Completion Date: October 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Ocular Bandage Gel (OBG)
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.
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.
Other: Bandage Contact Lens (BCL)
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.
Device: 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.
Outcome Measures
  • Primary Outcome Measures: 1. Complete corneal re-epithelialization on Day 3 [ Time Frame: Day 3 (72 hours) ]
    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.
  • Secondary Outcome Measures: 1. Time to corneal re-epithelialization [ Time Frame: Day 3 (72 hours) ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 22 to 50 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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.

Contacts and Locations
Contacts
Locations

United States, South Dakota
Vance Thompson Vision
Sioux Falls

Sponsors and Collaborators

Eyegate Pharmaceuticals, Inc.

Investigators

Study Director: Barbara Wirostko, M.D. EyeGate

More Information