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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol etabonate and tobramycin | Experimental | Drug: Zylet (loteprednol etabonate and tobramycin) |
|
| Loteprednol etabonate | Active Comparator | Drug: Lotemax (loteprednol etabonate) |
|
| Tobramycin | Active Comparator | Drug: Tobramycin |
|
| Vehicle | Placebo Comparator | Vehicle of Zylet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loteprednol etabonate and tobramycin | Drug | Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Ophthalmology of Erie | Erie | Pennsylvania | 16501 | United States |
A total of 137 pediatric subjects, 0 to 6 years of age, of either gender and any race, who had a clinical diagnosis of blepharoconjunctivitis in at least one eye were randomized in this study. 126 Participants completed the study.
This study was conducted at 17 sites in the United States. First participant was enrolled on 6/26/2008 and last participant visit was 3/24/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol Etabonate and Tobramycin | Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID). |
| FG001 | Loteprednol Etabonate | Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID). |
| FG002 | Tobramycin | Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID). |
| FG003 | Vehicle | Vehicle of Zylet. One or two drops in study eye four times a day (QID). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol Etabonate and Tobramycin | Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID). |
| BG001 | Loteprednol Etabonate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study eye, ITT Population, Non-missing data | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 15 days |
|
15 days
Safety population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loteprednol Etabonate and Tobramycin | Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory distress | Infections and infestations | MedDRA (12.0) | Systematic Assessment | Severe respiratory distress with moderate otitis media, unrelated to study drug or participation but due to concurrent illness. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Medra | Systematic Assessment | Non-ocular AE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tuyen Ong, MD, MRCOphth | Bausch & Lomb Incorporated | (973) 360-6389 | tuyen.ong@bausch.com |
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| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| loteprednol etabonate | Drug | Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days. |
|
|
| Tobramycin | Drug | Topical ocular administration of Tobramycin QID for 14 days. |
|
| Vehicle of Zylet | Drug | Topical ocular administration of the vehicle of Zylet QID for 14 days. |
|
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 |
| Protocol Violation |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Screen Failure |
|
Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
| BG002 | Tobramycin | Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID). |
| BG003 | Vehicle | Vehicle of Zylet. One or two drops in study eye four times a day (QID). |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Tobramycin | Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID). |
| OG003 | Vehicle | Vehicle of Zylet. One or two drops in study eye four times a day (QID). |
|
|
| 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. | Study eye, ITT population, non-missing data | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Day 3 |
|
|
|
| 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. | Study eye ITT population, subjects with non-missing data | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Day 7 |
|
|
|
| 2 |
| 34 |
| 2 |
| 34 |
| EG001 | Loteprednol Etabonate | Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID). | 2 | 35 | 2 | 35 |
| EG002 | Tobramycin | Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID). | 2 | 34 | 2 | 34 |
| EG003 | Vehicle | Vehicle of Zylet. One or two drops in study eye four times a day (QID). | 1 | 33 | 2 | 33 |
|
| Bronchiolitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment | Bronchiolitis and dehydration unrelated to study drug or participation but due to concurrent illness. |
|
|
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |