CompletedNot Applicable

Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy ("PRK")

United States250 participantsStarted 2019-06-25

Plain-language summary

Prospective, randomized, masked (reading center), controlled pivotal study of Ocular Bandage Gel (OBG) vs. a bandage contact lens (BCL) in subjects who have undergone bilateral photorefractive keratectomy (PRK).

Who can participate

Age range22 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Undergone PRK with a fresh epithelial defect. * Best corrected visual acuity (BCVA) of 20/20 or better at baseline Exclusion Criteria: * History of systemic disorders that may affect post-operative healing. * Corneal pathology that would affect wound re-epithelization. * Use of medications that may affect the rate of corneal healing. * Pregnant or lactating females.

What they're measuring

Complete corneal re-epithelialization on Day 3

Timeframe: Day 3 (72 hours)

Trial details

NCT IDNCT03938883

SponsorEyegate Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-01

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