Trials / Completed
CompletedNCT03163641
Safety and Effectiveness of OBG vs.a Bandage Contact Lens for Large Corneal Epithelial Defects in Patients Post-PRK.
A Randomized, Masked (Reading Center), Prospective Pilot Study of the Safety and Effectiveness of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid Applied Topically, Versus a Bandage Contact Lens for Acceleration of Re-epithelialization of Large Corneal Epithelial Defects in Patients Having Undergone Photorefractive Keratectomy (PRK).
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Eyegate Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Acuvue Oasys | Bandage Contact Lens |
| DEVICE | Ocular Bandage Gel | 0.75% crosslinked HA |
Timeline
- Start date
- 2018-08-05
- Primary completion
- 2018-10-31
- Completion
- 2018-11-08
- First posted
- 2017-05-23
- Last updated
- 2020-12-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03163641. Inclusion in this directory is not an endorsement.