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

Bausch + Lomb

Status and phase

Completed

Phase 4

Conditions

Inflammation

Treatments

Drug: Loteprednol etabonate 0.5% and tobramycin 0.3%

Drug: Dexamethasone 0.1% and tobramycin 0.3%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00532961

372

Details and patient eligibility

About

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.

Enrollment

310 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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