Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
I-ZIP Ocular Bandage Pivotal Study
This study is not yet open for participant recruitment.
Verified by I-Therapeutix, Inc., October 2008
Sponsored by: I-Therapeutix, Inc.
Information provided by: I-Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT00774228
  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

MedlinePlus related topics: Cataract
U.S. FDA Resources
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

Further study details as provided by I-Therapeutix, Inc.:

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

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

Contacts
Contact: Suzanne LaScalza 781-902-1614 slascalza@itherapeutix.com
Contact: Deepa Mulani 781-902-1623 dmulani@itherapeutix.com

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

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

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

Study placed in the following topic categories:
Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 16, 2009