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To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LE Gel | Experimental | A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LE Gel | Drug | Single drop of LE Gel 0.5% administered to the study eye on visit 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | 6 hours |
| Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | 9 hours |
| Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | 12 hours |
| Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery Schafer, OD, MS | Bausch & Lomb Incorporated | Principal Investigator |
| Raphaele Siou Mermet, MD, MS | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Research Clinic | Rochester | New York | 14609 | United States |
A total of 17 participants were screened for this study. Of those screened, 12 participants were included to receive treatment; these subjects constituted the Safety population. No participants discontinued from the study.
Single center, open label, single dose study in healthy volunteers. First participant enrolled 01/08/2013, last participant exited: 01/18/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | LE Gel | A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears. LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LE Gel | A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears. LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window. | Posted | Mean | Standard Deviation | μg/g | 6 hours |
|
24 hours
All 12 subjects were exposed to a single dose of LE Gel.
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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 | LE Gel | A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears. LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment | Non-Ocular Treatment-Emergent Adverse Events Population: Safety |
All 12 subjects were exposed to a single dose of LE Gel.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raphaële Siou-Mermet, MD, MS | Bausch & Lomb Incorporated | +33160871491 | raphaele.siou-mermet@bausch.com |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window. | Posted | Mean | Standard Deviation | μg/g | 9 hours |
|
|
|
| Primary | Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window. | Posted | Mean | Standard Deviation | μg/g | 12 hours |
|
|
|
| Primary | Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window. | Posted | Mean | Standard Deviation | μg/g | 24 hours |
|
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| 0 |
| 12 |
| 1 |
| 12 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |