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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol/Tobramycin | Experimental | 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension |
|
| Vehicle | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loteprednol etabonate/tobramycin opthalmic suspension | Drug | Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events | Study eye - Safety Population, At all visits 1,2,3 | day 1, day 8, day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigators Global Assessment of the Clinical Condition | The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened. | Visit 3, day 8 |
| Assessment of Ocular Signs in the Study Eye - Visit 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy L Comstock, OD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Ophthalmology of Erie | Erie | Pennsylvania | 16501 | United States |
108 subjects were randomized to receive loteprednol/tobramycin or its vehicle in a 2:1 ratio. Subjects will receive warm compress lid treatment 2 times daily, before administration of study medication (as applicable) for the 14-day treatment duration.
108 subjects aged 0-6 years with lid inflammation were recruited from 15 clinic locations in the US. First subject was enrolled on 11/07/2006, last subject visit was 1/5/2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol/Tobramycin | 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days |
| FG001 | Vehicle | Vehicle used in the study drug administered into affected eye(s) for 14 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol/Tobramycin | 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days |
| BG001 | Vehicle | Vehicle used in the study drug administered into affected eye(s) for 14 days |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Investigators Global Assessment of the Clinical Condition | The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened. | Efficacy Sample, subjects with non-missing data. Day 15 (Visit 3) | Posted | Number | Participants | Visit 3, day 8 |
|
14 days
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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/Tobramycin | 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bilateral subdural hematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Comstock OD | Bausch & Lomb | (585) 338-6631 | tcomstock@bausch.com |
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| ID | Term |
|---|---|
| D017043 | Chalazion |
| D006726 | Hordeolum |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D015818 |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
|
| vehicle | Drug | topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication. |
|
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. |
| Visit 1 (day 1) |
| Assessment of Ocular Signs in the Study Eye - Visit 2 | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. | Visit 2 (day 8) |
| Assessment of Ocular Signs in the Study Eye - Visit 3 | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. | Visit 3 (day 15) |
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
|
| Primary | Treatment Emergent Adverse Events | Study eye - Safety Population, At all visits 1,2,3 | Safety population, Study eye | Posted | Number | participants | day 1, day 8, day 15 |
|
|
|
| Secondary | Assessment of Ocular Signs in the Study Eye - Visit 1 | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. | Efficacy sample, non-missing data | Posted | Mean | Standard Deviation | Units on a scale 0-4 | Visit 1 (day 1) |
|
|
|
| Secondary | Assessment of Ocular Signs in the Study Eye - Visit 2 | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. | Efficacy population - Study eye | Posted | Mean | Standard Deviation | Units on a scale 0-4 | Visit 2 (day 8) |
|
|
|
| Secondary | Assessment of Ocular Signs in the Study Eye - Visit 3 | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. | Efficacy sample - Study eye | Posted | Mean | Standard Deviation | Units on a scale 0-4 | Visit 3 (day 15) |
|
|
|
| 1 |
| 72 |
| 0 |
| 72 |
| EG001 | Vehicle | Vehicle used in the study drug administered into affected eye(s) for 14 days | 0 | 36 | 0 | 36 |
The results of the study may be published or presented by the investigator(s) after the review by, and in consultation and agreement with Bausch & Lomb, and such that confidential or proprietary information is not disclosed.
Prior to publication or presentation, a copy of the final text should be forwarded by the investigator(s) to Bausch & Lomb or its designee, for comment.
| Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015817 | Eye Infections |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Eyelid edema |
|
| Palpebral Conjunctival Injection |
|
| Meibomian Plugging |
|
| Palpebral Conjunctival Injection |
|
| Meibomian Plugging |
|
| Palpebral Conjunctival Injection |
|
| Meibomian Plugging |
|