Ocular Bandage Gel (OBG) Pivotal Trial in Patients Undergoing Photorefractive Keratectomy ("PRK")
NCT ID: NCT03938883
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2019-06-25
2019-10-10
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ocular Bandage Gel (OBG)
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.
Ocular Bandage Gel (OBG)
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.
Bandage Contact Lens (BCL)
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.
Bandage Contact Lens (BCL)
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.
Interventions
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Ocular Bandage Gel (OBG)
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.
Bandage Contact Lens (BCL)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity (BCVA) of 20/20 or better at baseline
Exclusion Criteria
* Corneal pathology that would affect wound re-epithelization.
* Use of medications that may affect the rate of corneal healing.
* Pregnant or lactating females.
22 Years
50 Years
ALL
Yes
Sponsors
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Eyegate Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Wirostko, M.D.
Role: STUDY_DIRECTOR
EyeGate
Locations
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Vance Thompson Vision
Sioux Falls, South Dakota, United States
Countries
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References
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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.
Other Identifiers
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EYEGATE-034
Identifier Type: -
Identifier Source: org_study_id