Trials / Completed
CompletedNCT00774228
I-ZIP Ocular Bandage Pivotal Study
Clinical Evaluation of the I-ZIP® Ocular Bandage as a Protective Ocular Bandage in Subjects Undergoing Clear Corneal Cataract Surgery With IOL Implantation: A Pivotal Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 420 (actual)
- Sponsor
- Ocular Therapeutix, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and performance of the I-ZIP Ocular Bandage in subjects undergoing uneventful unilateral clear corneal phacoemulsification with foldable monofocal intraocular lens (IOL) implantation compared with the Oasis 24-hour Soft Shield Collagen Corneal Shield (Oasis Medical, Inc. Glendora, California) for providing ocular protection and relief of pain or discomfort in the acute post-operative period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | I-ZIP Ocular Bandage | |
| DEVICE | Oasis 24 Hour Soft Shield Collagen Corneal Shield |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2009-07-01
- Completion
- 2009-08-01
- First posted
- 2008-10-17
- Last updated
- 2021-09-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00774228. Inclusion in this directory is not an endorsement.