Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
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ClinicalTrials.gov Identifier: NCT00705159 |
Recruitment Status :
Completed
First Posted : June 25, 2008
Results First Posted : August 11, 2011
Last Update Posted : March 24, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Conjunctivitis | Drug: loteprednol etabonate and tobramycin Drug: loteprednol etabonate Drug: Tobramycin Drug: Vehicle of Zylet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 137 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | May 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: Loteprednol etabonate and tobramycin
Drug: Zylet (loteprednol etabonate and tobramycin)
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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)
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Drug: loteprednol etabonate
Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
Other Name: Lotemax |
Active Comparator: Tobramycin
Drug: Tobramycin
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Drug: Tobramycin
Topical ocular administration of Tobramycin QID for 14 days. |
Placebo Comparator: Vehicle
Vehicle of Zylet
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Drug: Vehicle of Zylet
Topical ocular administration of the vehicle of Zylet QID for 14 days. |
- 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.
- 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.

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Ages Eligible for Study: | 1 Week to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705159
United States, Pennsylvania | |
Pediatric Ophthalmology of Erie | |
Erie, Pennsylvania, United States, 16501 |
Responsible Party: | Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT00705159 |
Other Study ID Numbers: |
550 |
First Posted: | June 25, 2008 Key Record Dates |
Results First Posted: | August 11, 2011 |
Last Update Posted: | March 24, 2015 |
Last Verified: | March 2015 |
Blepharokeratoconjunctivitis |
Conjunctivitis Conjunctival Diseases Eye Diseases Loteprednol Etabonate |
Tobramycin Anti-Bacterial Agents Anti-Infective Agents Anti-Allergic Agents |