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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).

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03163641
Enrollment
45
Registered
2017-05-23
Start date
2018-08-05
Completion date
2018-11-08
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Epithelial Wound

Keywords

Photorefractive Keratectomy, Corneal Defect

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.

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.

Interventions

DEVICEAcuvue Oasys

Bandage Contact Lens

DEVICEOcular Bandage Gel

0.75% crosslinked HA

Sponsors

Eyegate Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
22 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Able and willing to comply with the protocol

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Time to corneal re-epithelization post PRKDay 3Time to corneal re-epithelization post PRK

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026