I-ZIP Ocular Bandage Pivotal Study

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: I-ZIP Ocular Bandage; Device: Oasis 24 Hour Soft Shield Collagen Corneal Shield

• Registration Number: NCT00774228
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-ZIP Ocular Bandage	I-ZIP Ocular Bandage	I-Zip bandage application
Oasis 24 hour Soft Shield Collagen Corneal Shield	Oasis 24 Hour Soft Shield Collagen Corneal Shield	Oasis shield application

Primary Outcome Measures

Name	Time	Method
Device remains localized over corneal incision	24 hours post operative

Secondary Outcome Measures

Name	Time	Method
Adverse ocular events	30 days post operative

Trial Locations

Locations (1)

I-Therapeutix, Inc.; 🇺🇸 Waltham, Massachusetts, United States