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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532961
• Other study ID #: 372
• Status: Completed
• Phase: Phase 4
• First received: September 20, 2007
• Last updated: December 7, 2011
• Start date: February 2005
• Est. completion date: June 2005

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: June 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular comfort/tolerability		Day 1, 3, 8, 15, 22 and 29	No
Primary	Intraocular pressure measurements		Day 1, 3, 8,15, 22 and 29	No
Secondary	Assessment of safety		Througout 28-day study	No