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I-ZIP Ocular Bandage Pivotal Study

This study has been completed.
Sponsor:
Information provided by:
Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier:
NCT00774228
First received: October 16, 2008
Last updated: August 7, 2009
Last verified: August 2009
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Ocular Therapeutix, Inc.:

Study Start Date: November 2008
Arms Assigned Interventions
Experimental: I-ZIP Ocular Bandage Device: I-ZIP Ocular Bandage
Active Comparator: Oasis 24 hour Soft Shield Collagen Corneal Shield Device: Oasis 24 Hour Soft Shield Collagen Corneal Shield

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a cataract and is expected to undergo unilateral clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber monofocal intraocular lens through an incision ≤ 3.5mm in width measured after IOL implantation using internal calipers.

Exclusion Criteria:

  • Any intraocular inflammation in the study eye that was present during the screening slit-lamp examination or presence of ocular pain in the operative eye as rated on the pre-operative NRPS
  • Previous surgery (laser or incisional) or ocular trauma to the operative eye or planned multiple procedures during cataract/IOL implantation surgery
  • Potential BCVA in fellow eye worse than 20/40 as assessed by the clinical Investigator
  • Active or history of chronic or recurrent inflammatory eye disease (iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis), evidence of acute external ocular infections, intraocular infection, dysthyroid ophthalmopathy, nasolacrimal duct obstruction, active chalazion, uncontrolled blepharitis, uncontrolled and clinically significant dry eye syndrome, anything more than trace guttata (>10 guttae in the central 6 mm of cornea), evidence of glaucoma/glaucoma suspect, corneal dystrophy or other ocular disease that would interfere with study evaluations
  • Subject is currently receiving antineoplastic therapy
  • Use of topical ocular steroids within 14 days and/or systemic steroids (excluding inhalants) within 30 days prior to surgery.
  • Subject is an insulin-dependent diabetic or has background diabetic retinopathy (BDR), proliferative diabetic retinopathy (PDR) or compromised macular function
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774228

Locations
United States, Massachusetts
I-Therapeutix, Inc.
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Ocular Therapeutix, Inc.
  More Information

No publications provided by Ocular Therapeutix, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical, Regulatory, and Quality, I-Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT00774228     History of Changes
Other Study ID Numbers: ITX-08-002
Study First Received: October 16, 2008
Last Updated: August 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Ocular Therapeutix, Inc.:
Cataract or intraocular lens placement surgery

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 27, 2014