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

Phase 4

Completed

• Conditions: Inflammation
• Interventions: Drug: Loteprednol etabonate 0.5% and tobramycin 0.3%; Drug: Dexamethasone 0.1% and tobramycin 0.3%

• Registration Number: NCT00532961
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-04
• Study Completion: 2005-06
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-21
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• in good general health based on investigator judgment
• able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study
• possessing a best corrected visual acuity of at least 20/40 in each eye
• for females, using reliable contraception and a negative urine pregnancy test prior to study entry

Exclusion Criteria

• contact lenses worn within 30 days prior to enrollment or during study period
• known hypersensitivity to study medication or any component
• presence of significant ocular or systemic disease that might interfere with the interpretation of the results
• a need for administration of chronic topical ocular or systemic medications of any kind during the study.
• participation in an opthalmic drug or device research study within 30 days prior to entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zylet	Loteprednol etabonate 0.5% and tobramycin 0.3%	Zylet (loteprednol etabonate and tobramycin)
Tobradex	Dexamethasone 0.1% and tobramycin 0.3%	TobraDex (dexamethasone and tobramycin)

Primary Outcome Measures

Name	Time	Method
Ocular comfort/tolerability	Day 1, 3, 8, 15, 22 and 29
Intraocular pressure measurements	Day 1, 3, 8,15, 22 and 29

Secondary Outcome Measures

Name	Time	Method
Assessment of safety	Througout 28-day study