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Completed

NCT Number: NCT03938883

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

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).

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Key information

Conditions

Ophthalmology Laser Assisted Surgery Photorefractive Keratectomy ("PRK") Refractive Surgery

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

About this study

This is a 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).

Study subjects will be evaluated and, if eligible following PRK, will receive the study treatment in a 1:1 randomization with both eyes receiving the same treatment.

Sites will capture the time that PRK surgery OU is completed. Sites will enroll eligible subjects and randomly assign a subject to Treatment Group (OBG) or Control Group (BCL). One eye will be randomized as the designated "study eye" for statistical purposes.

The reading center will be masked as to the randomization assignments. Both eyes will receive the same randomized assignment and both eyes of each subject will be evaluated at all timepoints.

The defect in both eyes of all subjects will be measured starting at Day 2 (48 hours after PRK). The slit lamp photos are to be collected at 48 hours (±1 hour) from PRK completion in both eyes.

The BCL in the Control Group eyes will be removed daily starting at Day 2 for slit lamp photos. Slit lamp measurements, as well as photography of the epithelial defect (without and with fluorescein), will be taken of both eyes of all subjects. Photos will be evaluated by a masked reading center.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ocular Bandage Gel (OBG)

Device

A modified form of the natural polymer hyaluronic acid, which is a gel that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries including surgical trauma.

Other names: crosslinked thiolated carboxymethyl hyaluronic acid ("CMHA-S")

Bandage Contact Lens (BCL)

Device

A bandage contact lens protects an injured or diseased cornea from the mechanical rubbing of the blinking eyelids, therefore allowing it to heal. It is a normal (usually soft, but not always) contact lens has no power. It is not intended to improve your vision.

Other names: Acuvue Oasys

Primary outcomes

  1. Complete corneal re-epithelialization on Day 3

    Time frame: Day 3 (72 hours)

    Evaluated by a masked reading center using digital photography of fluorescein stained slit lamp photos and image analysis. Proportion of eyes following PRK surgery with complete corneal re-epithelization of the epithelial defect on Day 3 and no recurrent erosions.

Secondary outcomes

  1. Time to corneal re-epithelialization

    Time frame: Day 3 (72 hours)

    Evaluated by a masked reading center using digital photography of fluorescein stained slit lamp photos and image analysis. Time to closure in eyes following PRK surgery with complete re-epithelialization and no recurrent erosions.

Sponsors and collaborators

Lead sponsor

Eyegate Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized Masked (Reading Center), Controlled, Prospective Pivotal Study of the Effectiveness and Safety of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid (HA) Applied Topically, Versus a Bandage Contact Lens (BCL) in Accelerating Re-epithelialization of Large Corneal Epithelial Defects in Patients Having Undergone Photorefractive Keratectomy (PRK).

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 6, 2019
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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