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

NCT ID: NCT03163641

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-05

Study Completion Date

2018-11-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Corneal Epithelial Wound

Keywords

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Photorefractive Keratectomy, Corneal Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Used a masked reading center to review the corneal defect staining.

Study Groups

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Treatment 1

Ocular Bandage Gel

Group Type EXPERIMENTAL

Ocular Bandage Gel

Intervention Type DEVICE

0.75% crosslinked HA

Treatment 2

Ocular Bandage Gel

Group Type EXPERIMENTAL

Ocular Bandage Gel

Intervention Type DEVICE

0.75% crosslinked HA

Control Group

Artificial tears with Acuvue Oasys

Group Type ACTIVE_COMPARATOR

Acuvue Oasys

Intervention Type DEVICE

Bandage Contact Lens

Ocular Bandage Gel

Intervention Type DEVICE

0.75% crosslinked HA

Interventions

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Acuvue Oasys

Bandage Contact Lens

Intervention Type DEVICE

Ocular Bandage Gel

0.75% crosslinked HA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Able and willing to comply with the protocol

Exclusion Criteria

\-
Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eyegate Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Wirostko, M.D.

Role: STUDY_DIRECTOR

Eyegate Pharmaceuticals, Inc.

Locations

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Houston, Texas

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 29703289 (View on PubMed)

Other Identifiers

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EYEGATE-033

Identifier Type: -

Identifier Source: org_study_id