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Patient charts will be reviewed to evaluate the incidence of intraocular pressure spikes while on Loteprednol etabonate ophthalmic suspension 0.5%, Loteprednol etabonate (0.5%) and tobramycin (0.3%)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Loteprednol etabonate ophthalmic suspension 0.5% |
| |
| 2 | Loteprednol etabonate (0.5%) and tobramycin (0.3%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol etabonate ophthalmic suspension 0.5% | Drug | Apply one to two drops of Loteprednol etabonate ophthalmic suspension 0.5% into the conjunctival sac as prescribed by your physician |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Elevated Intraocular Pressure (IOP) During Treatment | Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days. | 55 days |
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Inclusion Criteria:
Exclusion Criteria:
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Data to be collected will include: Patient Demographics (age, gender, race, eye color), medical and ophthalmic history, active ophthalmic disease, active systemic diseases, concomitant medications, procedure/condition for which Lotemax®/Zylet® were prescribed, underlying etiology requiring PK (if applicable), history of prior ocular surgery, prior history of steroid response, history of glaucoma, start/stop date of steroid treatment, IOP before and after steroid treatment, treatment-related adverse events, and any other notes/information that the investigator feels may be important.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maclean | Virginia | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol Etabonate Ophthalmic Suspension 0.5% | Loteprednol etabonate ophthalmic suspension 0.5% |
| FG001 | Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) | Loteprednol etabonate (0.5%) and tobramycin (0.3%) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol Etabonate Ophthalmic Suspension 0.5% | Loteprednol etabonate ophthalmic suspension 0.5% |
| BG001 | Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) | Loteprednol etabonate (0.5%) and tobramycin (0.3%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | 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 | Mean Elevated Intraocular Pressure (IOP) During Treatment | Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days. | Intent to treat, which included all patients in the study. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 55 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 Etabonate Ophthalmic Suspension 0.5% | Loteprednol etabonate ophthalmic suspension 0.5% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma surgery | Surgical and medical procedures | Systematic Assessment | Type of Glaucoma Surgery:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| 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 (0.5%) and tobramycin (0.3%). | Drug | Apply one or two drops of Loteprednol etabonate (0.5%) and tobramycin (0.3%) into the conjunctival sac as prescribed by your physician. |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Loteprednol etabonate (0.5%) and tobramycin (0.3%)
|
|
| 0 |
| 43 |
| 4 |
| 43 |
| EG001 | Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) | Loteprednol etabonate (0.5%) and tobramycin (0.3%) | 0 | 7 | 0 | 7 |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |