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Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex

NCT00532961 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2011-12-08

No results posted yet for this study

Summary

Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.

Conditions

Interventions

DRUG

Loteprednol etabonate 0.5% and tobramycin 0.3%

ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days

DRUG

Dexamethasone 0.1% and tobramycin 0.3%

ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Timothy L Comstock, DO · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2005-04-30
Completion
2005-06-30

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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 NCT00532961 on ClinicalTrials.gov