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I-ZIP Ocular Bandage Pivotal Study

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ClinicalTrials.gov Identifier: NCT00774228
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : August 10, 2009
Sponsor:
Information provided by:
Ocular Therapeutix, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Cataract Device: I-ZIP Ocular Bandage Device: Oasis 24 Hour Soft Shield Collagen Corneal Shield Not Applicable

Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arm Intervention/treatment
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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774228


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

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
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: August 10, 2009
Last Verified: August 2009

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases