Clinical trial NCT03938883: Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy ("PRK")
Official 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ophthalmology
Photorefractive Keratectomy ("PRK")
Laser Assisted Surgery
Refractive Surgery
Keywords: Photorefractive Keratectomy, Corneal Defect
Lead sponsor: Eyegate Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-06
Enrollment: 250
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete corneal re-epithelialization on Day 3
timeFrame: Day 3 (72 hours)
Secondary outcomes:
measure: Time to corneal re-epithelialization
timeFrame: Day 3 (72 hours)
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
affiliation: EyeGate
name: Barbara Wirostko, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.