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Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00705159
First received: June 20, 2008
Last updated: March 4, 2015
Last verified: March 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Conjunctivitis | Drug: loteprednol etabonate and tobramycin Drug: loteprednol etabonate Drug: Tobramycin Drug: Vehicle of Zylet | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis |
Resource links provided by NLM:
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- Change From Baseline in the Total Blepharoconjunctivitis Grade. [ Time Frame: Baseline to 15 days ]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.
Secondary Outcome Measures:
- Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2 [ Time Frame: Baseline to Day 3 ]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.
- Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 [ Time Frame: Baseline to Day 7 ]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.
| Enrollment: | 137 |
| Study Start Date: | June 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Loteprednol etabonate and tobramycin
Drug: Zylet (loteprednol etabonate and tobramycin)
|
Drug: loteprednol etabonate and tobramycin
Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
Other Name: Zylet
|
|
Active Comparator: Loteprednol etabonate
Drug: Lotemax (loteprednol etabonate)
|
Drug: loteprednol etabonate
Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
Other Name: Lotemax
|
|
Active Comparator: Tobramycin
Drug: Tobramycin
|
Drug: Tobramycin
Topical ocular administration of Tobramycin QID for 14 days.
|
|
Placebo Comparator: Vehicle
Vehicle of Zylet
|
Drug: Vehicle of Zylet
Topical ocular administration of the vehicle of Zylet QID for 14 days.
|
Eligibility| Ages Eligible for Study: | up to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705159
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705159
Locations
| United States, Pennsylvania | |
| Pediatric Ophthalmology of Erie | |
| Erie, Pennsylvania, United States, 16501 | |
Sponsors and Collaborators
Bausch & Lomb Incorporated
More Information
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT00705159 History of Changes |
| Other Study ID Numbers: |
550 |
| Study First Received: | June 20, 2008 |
| Results First Received: | June 14, 2011 |
| Last Updated: | March 4, 2015 |
Keywords provided by Bausch & Lomb Incorporated:
|
Blepharokeratoconjunctivitis |
Additional relevant MeSH terms:
|
Conjunctivitis Conjunctival Diseases Eye Diseases Tobramycin |
Loteprednol Etabonate Anti-Bacterial Agents Anti-Infective Agents Anti-Allergic Agents |
ClinicalTrials.gov processed this record on July 21, 2017