Safety and Effectiveness of OBG vs.a Bandage Contact Lens for Large Corneal Epithelial Defects in Patients Post-PRK.
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).
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 23, 2017
CompletedStudy Start
First participant enrolled
August 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2018
CompletedDecember 17, 2020
January 1, 2019
3 months
May 17, 2017
December 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to corneal re-epithelization post PRK
Time to corneal re-epithelization post PRK
Day 3
Study Arms (3)
Treatment 1
EXPERIMENTALOcular Bandage Gel
Treatment 2
EXPERIMENTALOcular Bandage Gel
Control Group
ACTIVE COMPARATORArtificial tears with Acuvue Oasys
Interventions
Eligibility Criteria
You may qualify if:
- Able and willing to comply with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Houston, Texas
Houston, Texas, 77077, United States
Related Publications (1)
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.
PMID: 29703289RESULT
Study Officials
- STUDY DIRECTOR
Barbara Wirostko, M.D.
Eyegate Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Used a masked reading center to review the corneal defect staining.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2017
First Posted
May 23, 2017
Study Start
August 5, 2018
Primary Completion
October 31, 2018
Study Completion
November 8, 2018
Last Updated
December 17, 2020
Record last verified: 2019-01