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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00705159
Other study ID # 550
Secondary ID
Status Completed
Phase Phase 4
First received June 20, 2008
Last updated March 4, 2015
Start date June 2008
Est. completion date May 2010

Study information

Verified date March 2015
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

The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date May 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Years
Eligibility Inclusion Criteria:

- children 0-6 years of age.

- clinical diagnosis of blepharoconjunctivitis

- Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.

- Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

- Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.

- Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.

- Subjects who are monocular.

- Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.

- Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
loteprednol etabonate and tobramycin
Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
loteprednol etabonate
Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
Tobramycin
Topical ocular administration of Tobramycin QID for 14 days.
Vehicle of Zylet
Topical ocular administration of the vehicle of Zylet QID for 14 days.

Locations

Country Name City State
United States Pediatric Ophthalmology of Erie Erie Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in the Total Blepharoconjunctivitis Grade. Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. Baseline to 15 days No
Secondary Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2 Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. Baseline to Day 3 No
Secondary Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. Baseline to Day 7 No
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