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This study is being conducted to compare the safety and efficacy of loteprednol etabonate 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 0.5% ophthalmic suspension |
|
| Vehicle | Placebo Comparator | Vehicle of loteprednol etabonate ophthalmic suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol etabonate | Drug | Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Anterior Chamber Cells. | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells | Visit 5 (Postoperative day 8) |
| Grade 0 Pain | Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain | Visit 5 (Postoperative day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Anterior Chamber Cells | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells | Visit 4-7 (postoperative day 3-18) |
| Grade 0 Pain |
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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 | 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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A total of 407 participants, who were candidates for routine, uncomplicated cataract surgery, were enrolled in the study, 400 participants completed the study.
This study was conducted at 22 enrolling sites; 2 in the European Union (EU) and 20 in the United States (US). First participant was enrolled on 2/19/2010 and last participant completed the study on 9/3/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol Etabonate | Loteprednol etabonate 0.5% ophthalmic suspension |
| FG001 | Vehicle | Vehicle of loteprednol etabonate ophthalmic suspension. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol Etabonate | Loteprednol etabonate 0.5% ophthalmic suspension |
| BG001 | Vehicle | Vehicle of loteprednol etabonate ophthalmic suspension. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Intent to treat Population (ITT) |
| 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. | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells | Intention to treat (ITT) population | Posted | Number | participants | Visit 5 (Postoperative 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 Etabonate | Loteprednol etabonate 0.5% ophthalmic suspension |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior Chamber Inflammation | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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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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| Vehicle of Loteprednol Etabonate | Drug | Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14. |
|
Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain
| Visits 4-7 (Postoperative days 3-18) |
| Resolution of Anterior Chamber Flare | Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe. | Visit 4-7 (postoperative day 3-18) |
| Protocol Violation |
|
| Acute cholecystitis |
|
| Excluded Medications |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Grade 0 Pain | Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain | Intention to treat (ITT) population | Posted | Number | participants | Visit 5 (Postoperative day 8) |
|
|
|
| Secondary | Resolution of Anterior Chamber Cells | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells | Intention to treat population (ITT) | Posted | Number | participants | Visit 4-7 (postoperative day 3-18) |
|
|
|
| Secondary | Grade 0 Pain | Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain | Intention to treat population (ITT) | Posted | Number | participants | Visits 4-7 (Postoperative days 3-18) |
|
|
|
| Secondary | Resolution of Anterior Chamber Flare | Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe. | Intention to treat population (ITT) | Posted | Number | participants | Visit 4-7 (postoperative day 3-18) |
|
|
|
| 3 |
| 206 |
| 10 |
| 206 |
| EG001 | Vehicle | Vehicle of loteprednol etabonate ophthalmic suspension. | 1 | 201 | 24 | 201 |
| Cholecystitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA (12.0) | Systematic Assessment |
|
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 (Postoperative Day 15) |
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| Visit 7 (Postoperative Day 18) |
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| Visit 6 (Postoperative Day 15) |
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| Visit 7 (Postoperative Day 18) |
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| Visit 6 (Postoperative Day 15) |
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| Visit 7 (Postoperative Day 18) |
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