Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Zylet (loteprednol etabonate and tobramycin)
• Active Comparator: 2
  • TobraDex (dexamethasone and tobramycin)

Primary Measures

• Ocular comfort/tolerability outcomes including pain, stinging/burning, irritation, itchiness, foreign-body sensation, dryness, light sensitivity
  • Time Frame: At Day 1, 3, 8, 15, 22 and 29
    
• Intraocular pressure measurements
  • Time Frame: Day 1, 3,8,15,22 and 29
    

Secondary Measures

• Assessment of safety (adverse events, best corrected visual acuity, slit-lamp biomicroscopy, ophthalmoscopy)
  • Time Frame: Througout 28-day study
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bausch & Lomb, Inc.

Overall Clinical Trial Officials and Contacts

Timothy L Comstock, DO Study Director Bausch & Lomb, Inc.  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00532961

Study ID Number: 372

ClinicalTrials.gov Identifier: NCT00532961

Health Authority: United States: Food and Drug Administration