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Sponsored by: |
I-Therapeutix, Inc. |
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Information provided by: | I-Therapeutix, Inc. |
ClinicalTrials.gov Identifier: | NCT00774228 |
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.
Condition | Intervention |
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Cataract |
Device: I-ZIP Ocular Bandage Device: Oasis 24 Hour Soft Shield Collagen Corneal Shield |
Study Type: | Interventional |
Official Title: | 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 |
Study Start Date: | November 2008 |
Arms | Assigned Interventions |
---|---|
I-ZIP Ocular Bandage: Experimental | Device: I-ZIP Ocular Bandage |
Oasis 24 hour Soft Shield Collagen Corneal Shield: Active Comparator | Device: Oasis 24 Hour Soft Shield Collagen Corneal Shield |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Suzanne LaScalza | 781-902-1614 | slascalza@itherapeutix.com |
Contact: Deepa Mulani | 781-902-1623 | dmulani@itherapeutix.com |
United States, Massachusetts | |
I-Therapeutix, Inc. | |
Waltham, Massachusetts, United States, 02451 |
Responsible Party: | I-Therapeutix, Inc. ( Executive Vice President, Clinical, Regulatory, and Quality ) |
Study ID Numbers: | ITX-08-002 |
Study First Received: | October 16, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00774228 |
Health Authority: | United States: Food and Drug Administration |
Cataract or intraocular lens placement surgery |
Eye Diseases Cataract Lens Diseases |