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Sponsored by: |
Bausch & Lomb, Inc. |
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Information provided by: | Bausch & Lomb, Inc. |
ClinicalTrials.gov Identifier: | NCT00420628 |
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)
Condition | Intervention | Phase |
---|---|---|
Chalazion Hordeolum |
Drug: loteprednol etabonate 0.5% and tobramycin 0.3% opthalmic suspension Drug: vehicle |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects |
Estimated Enrollment: | 108 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: loteprednol etabonate 0.5% and tobramycin 0.3% opthalmic suspension
topical ophthalmic drug
|
2: Placebo Comparator |
Drug: vehicle
topical ophthalmic drug
|
Ages Eligible for Study: | up to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Timothy L Comstock | (585)338-6631 |
United States, Pennsylvania | |
Pediatric Ophthalmology of Erie | Recruiting |
Erie, Pennsylvania, United States, 16501 |
Study Director: | Timothy L Comstock, OD | Bausch & Lomb, Inc. |
Responsible Party: | Bausch & Lomb, Inc. ( Timothy L Comstock ) |
Study ID Numbers: | 459 |
Study First Received: | January 8, 2007 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00420628 |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Eye Infections, Bacterial Chalazion Tobramycin Eye Diseases |
Eye Infections Cysts Loteprednol etabonate Hordeolum Inflammation |
Anti-Infective Agents Anti-Bacterial Agents Neoplasms Therapeutic Uses |
Eyelid Diseases Anti-Allergic Agents Infection Pharmacologic Actions |