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CompletedNCT03163641Updated Dec 17, 2020

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

An interventional study of Acuvue Oasys and Ocular Bandage Gel in Corneal Epithelial Wound, sponsored by Eyegate Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 22 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Eyegate Pharmaceuticals, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2018, 7 years 11 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
22 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Corneal Epithelial Wound

Keywords

  • Photorefractive Keratectomy, Corneal Defect
03

In context

Lead sponsor

Eyegate Pharmaceuticals, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Able and willing to comply with the protocol

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Treatment 1

    Ocular Bandage Gel

    Device: Ocular Bandage Gel

  • Experimental
    Treatment 2

    Ocular Bandage Gel

    Device: Ocular Bandage Gel

  • Active comparator
    Control Group

    Artificial tears with Acuvue Oasys

    Device: Acuvue Oasys · Device: Ocular Bandage Gel

Interventions

  • DeviceAcuvue Oasys

    Bandage Contact Lens

  • DeviceOcular Bandage Gel

    0.75% crosslinked HA

06

What researchers measure

Primary outcomes

  1. Time to corneal re-epithelization post PRK

    Time to corneal re-epithelization post PRK

    Time frame: Day 3

07

Study locations

1 site
  • Houston, Texas
    Houston, Texas 77077, United States
08

References and documents

Publications

  • Durrie DS, Wolsey D, Thompson V, Assang C, Mann B, Wirostko B. Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy. J Cataract Refract Surg. 2018 Mar;44(3):369-375. doi: 10.1016/j.jcrs.2018.01.018. PubMed 29703289 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03163641
Lead sponsor
Eyegate Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 23, 2017
Start date
Aug 5, 2018
Primary completion
Oct 31, 2018
Completion
Nov 8, 2018
Last update
Dec 17, 2020

Study contacts

Barbara Wirostko, M.D.
study director · Eyegate Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Eyegate Pharmaceuticals, Inc.

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