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I-ZIP Ocular Bandage Pivotal Study

NCT00774228 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2021-09-29

No results posted yet for this study

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

Interventions

DEVICE

I-ZIP Ocular Bandage

DEVICE

Oasis 24 Hour Soft Shield Collagen Corneal Shield

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-07-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00774228 on ClinicalTrials.gov