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This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area.
This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area. Subjects will be assigned to one of three treatment arms on Day 0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Ocular Bandage Gel |
|
| Treatment 2 | Experimental | Ocular Bandage Gel |
|
| Control Group | Active Comparator | Artificial tears with Acuvue Oasys |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acuvue Oasys | Device | Bandage Contact Lens |
| |
| Ocular Bandage Gel |
| Measure | Description | Time Frame |
|---|---|---|
| Time to corneal re-epithelization post PRK | Time to corneal re-epithelization post PRK | Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Wirostko, M.D. | Eyegate Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston, Texas | Houston | Texas | 77077 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29703289 | Result | 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. |
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Used a masked reading center to review the corneal defect staining.
| Device |
0.75% crosslinked HA |
|