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

A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers

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.

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