I-ZIP Ocular Bandage Pivotal Study

NCT ID: NCT00774228

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I-ZIP Ocular Bandage

I-Zip bandage application

Group Type: EXPERIMENTAL

I-ZIP Ocular Bandage

Intervention Type: DEVICE

Oasis 24 hour Soft Shield Collagen Corneal Shield

Oasis shield application

Group Type: ACTIVE_COMPARATOR

Oasis 24 Hour Soft Shield Collagen Corneal Shield

Intervention Type: DEVICE

Interventions

I-ZIP Ocular Bandage

Intervention Type: DEVICE

Oasis 24 Hour Soft Shield Collagen Corneal Shield

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

I-Therapeutix, Inc.

Waltham, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21183106 (View on PubMed)

Other Identifiers

ITX-08-002

Identifier Type: -

Identifier Source: org_study_id