I-ZIP Ocular Bandage Pivotal Study

Ocular Therapeutix

Status

Completed

Conditions

Cataract

Treatments

Device: Oasis 24 Hour Soft Shield Collagen Corneal Shield

Device: I-ZIP Ocular Bandage

Study type

Interventional

Funder types

Industry

Identifiers

NCT00774228

ITX-08-002

Details and patient eligibility

About

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.

Enrollment

420 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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