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This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol Etabonate | Experimental | Loteprednol etabonate |
|
| Vehicle | Placebo Comparator | Vehicle of loteprednol etabonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle of Loteprednol Etabonate | Drug | 1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Anterior Chamber Cells (ACC). | Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp. | Visit 5 (Postoperative day 8) |
| Grade 0 Pain | Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants. | Visit 5 (Postoperative Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Anterior Chamber Cells. | Study eyes with complete resolution of anterior chamber cells (ACC) | At visits 4-7- postoperative day 3, 8,15 & 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Trusso | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Inc. | Rochester | New York | 14609 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24136301 | Derived | Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18. |
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406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.
This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol | Loteprednol etabonate 0.5% |
| FG001 | Vehicle | Vehicle of loteprednol etabonate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol | Loteprednol etabonate 0.5% |
| BG001 | Vehicle | Vehicle of loteprednol etabonate |
| 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 | Resolution of Anterior Chamber Cells (ACC). | Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp. | Intent to treat (ITT) population | Posted | Number | Eyes | Visit 5 (Postoperative day 8) | Eyes | Participants |
|
Visit 3 post-operative day 1 thru visit 7 postoperative day 18
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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 | Loteprednol etabonate 0.5% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid Macular Edema | Eye disorders | MedDRA (12.0) | Systematic Assessment | Unrelated to study drug, but probably related to study procedure |
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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 |
|---|---|
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Loteprednol Etabonate | Drug | 1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days. |
|
| Withdrawal by Subject |
|
| Investigator decision |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
|
|
| Secondary | Resolution of Anterior Chamber Cells. | Study eyes with complete resolution of anterior chamber cells (ACC) | Posted | Number | Eyes | At visits 4-7- postoperative day 3, 8,15 & 18 |
|
|
|
| Primary | Grade 0 Pain | Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants. | Intent to treat population (ITT) | Posted | Number | Eyes | Visit 5 (Postoperative Day 8) | Eyes | Participants |
|
|
|
|
| 1 |
| 203 |
| 0 |
| 203 |
| EG001 | Vehicle | Vehicle of loteprednol etabonate | 2 | 203 | 0 | 203 |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment | The event is serious, unexpected, unrelated to the study drug and the study procedure but rather possibly related to a concomitant illness in a predisposed patient |
|
| Heart Failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment | SAEs were unrelated to study drug |
|
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 |
| Visit 6 |
|
| Visit 7 |
|