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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03163641
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Eyegate Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Corneal Epithelial Wound Device: Acuvue Oasys Device: Ocular Bandage Gel Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Used a masked reading center to review the corneal defect staining.
Primary Purpose: Treatment
Official Title: A Randomized, Masked (Reading Center), Prospective Pilot Study of the Safety and Effectiveness of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid Applied Topically, Versus a Bandage Contact Lens for Acceleration of Re-epithelialization of Large Corneal Epithelial Defects in Patients Having Undergone Photorefractive Keratectomy (PRK).
Actual Study Start Date : August 5, 2018
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : November 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Treatment 1
Ocular Bandage Gel
Device: Ocular Bandage Gel
0.75% crosslinked HA

Experimental: Treatment 2
Ocular Bandage Gel
Device: Ocular Bandage Gel
0.75% crosslinked HA

Active Comparator: Control Group
Artificial tears with Acuvue Oasys
Device: Acuvue Oasys
Bandage Contact Lens

Device: Ocular Bandage Gel
0.75% crosslinked HA




Primary Outcome Measures :
  1. Time to corneal re-epithelization post PRK [ Time Frame: Day 3 ]
    Time to corneal re-epithelization post PRK



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to comply with the protocol

Exclusion Criteria:

-


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): NCT03163641


Locations
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United States, Texas
Houston, Texas
Houston, Texas, United States, 77077
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
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Study Director: Barbara Wirostko, M.D. Eyegate Pharmaceuticals, Inc.

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Responsible Party: Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03163641     History of Changes
Other Study ID Numbers: EYEGATE-033
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Eyegate Pharmaceuticals, Inc.:
Photorefractive Keratectomy, Corneal Defect