I-ZIP Ocular Bandage Pivotal Study

NCT00774228 | Completed

• 1 other identifier: ITX-08-002
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Cataract or intraocular lens placement surgery

Outcome Measures

Primary Outcomes (1)

• Device remains localized over corneal incision

  24 hours post operative

Secondary Outcomes (1)

• Adverse ocular events

  30 days post operative

Study Arms (2)

I-ZIP Ocular Bandage

EXPERIMENTAL

I-Zip bandage application

Device: I-ZIP Ocular Bandage

Oasis 24 hour Soft Shield Collagen Corneal Shield

ACTIVE COMPARATOR

Oasis shield application

Device: Oasis 24 Hour Soft Shield Collagen Corneal Shield

Interventions

I-ZIP Ocular Bandage DEVICE

I-ZIP Ocular Bandage

Oasis 24 Hour Soft Shield Collagen Corneal Shield DEVICE

Oasis 24 hour Soft Shield Collagen Corneal Shield

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead

Study Sites (1)

I-Therapeutix, Inc.

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

• Dell SJ, Hovanesian JA, Raizman MB, Crandall AS, Doane J, Snyder M, Masket S, Lane S, Fram N; Ocular Bandage Study Group. Randomized comparison of postoperative use of hydrogel ocular bandage and collagen corneal shield for wound protection and patient tolerability after cataract surgery. J Cataract Refract Surg. 2011 Jan;37(1):113-21. doi: 10.1016/j.jcrs.2010.11.001.

  PMID: 21183106 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)