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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Loteprednol Etabonate; Tobramycin

Criteria

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