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

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ClinicalTrials.gov Identifier: NCT03938883
Recruitment Status : Active, not recruiting
First Posted : May 6, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eyegate Pharmaceuticals, Inc.

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 Intervention/treatment Phase
Ophthalmology Photorefractive Keratectomy ("PRK") Laser Assisted Surgery Refractive Surgery Device: Ocular Bandage Gel (OBG) Device: Bandage Contact Lens (BCL) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 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)
Masking Description: Masked images will be sent to a central reading center
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 25, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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 Name: crosslinked thiolated carboxymethyl hyaluronic acid ("CMHA-S")

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.
Other Name: Acuvue Oasys




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.



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Ages Eligible for Study:   22 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938883


Locations
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United States, South Dakota
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
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Study Director: Barbara Wirostko, M.D. EyeGate

Publications:
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Responsible Party: Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03938883     History of Changes
Other Study ID Numbers: EYEGATE-034
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan developed or decided upon at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Eyegate Pharmaceuticals, Inc.:
Photorefractive Keratectomy, Corneal Defect
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents