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

NCT03938883 | Completed FDA Device

• 1 other identifier: EYEGATE-034
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Photorefractive Keratectomy, Corneal Defect

Outcome Measures

Primary Outcomes (1)

• Complete corneal re-epithelialization on Day 3

  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.

  Day 3 (72 hours)

Secondary Outcomes (1)

• Time to corneal re-epithelialization

  Day 3 (72 hours)

Study Arms (2)

Ocular Bandage Gel (OBG)

EXPERIMENTAL

Cross-linked Hyaluronic Acid 0.75%, regulated through CDRH (device). EyeGate Ocular Bandage Gel will be applied topically to both eyes (OU) four times a day. Ocular Bandage Gel use is discontinued once complete re-epithelialization has occurred in that eye.

Device: Ocular Bandage Gel (OBG)

Bandage Contact Lens (BCL)

OTHER

standard-of-care post-operative intervention following PRK. BCL (Acuvue® Oasys plano lens) applied OU. Bandage contact lens use is discontinued once complete re-epithelialization has occurred in that eye.

Device: Bandage Contact Lens (BCL)

Interventions

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.

Also known as: crosslinked thiolated carboxymethyl hyaluronic acid ("CMHA-S")

Ocular Bandage Gel (OBG)

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.

Also known as: Acuvue Oasys

Bandage Contact Lens (BCL)

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergone PRK with a fresh epithelial defect.
• Best corrected visual acuity (BCVA) of 20/20 or better at baseline

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eyegate Pharmaceuticals, Inc.: lead

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

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: 29703289 BACKGROUND

Study Officials

• Barbara Wirostko, M.D.

  EyeGate

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masked images will be sent to a central reading center
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects (all eyes) who receive any study treatment will be evaluable for safety analysis. All treatment assignments are assigned through 1:1 randomization with one eye designated as the "study eye" for statistical purposes. The final subject evaluability will be determined prior to breaking the code for masked treatment assignment and locking the database.

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: June 25, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 10, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)