Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol Etabonate | Experimental | Loteprednol Etabonate 0.5% |
|
| Vehicle | Placebo Comparator | Vehicle of Ophthalmic Loteprednol Etabonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol Etabonate | Drug | Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. | Postoperative day 8 (Visit 5) |
| Participants With Grade 0 (no) Pain | Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe | Postoperative day 8 (Visit 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Trusso | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornerstone Eye Wear | High Point | North Carolina | 27262 | United States |
405 participants, who were candidates for routine, uncomplicated cataract surgery were enrolled in the study.
This study was conducted at 16 sites in the US. The first participant was enrolled June 20, 2008 and the last participant visit was May 1, 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol Etabonate | Loteprednol Etabonate Ophthalmic Ointment 0.5% |
| FG001 | Vehicle | Vehicle of Ophthalmic Loteprednol Etabonate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol Etabonate | Loteprednol Etabonate Ophthalmic Ointment 0.5% |
| BG001 | Vehicle | Vehicle of Ophthalmic 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 | Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. | Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no. | Posted | Number | participants | Postoperative day 8 (Visit 5) |
|
Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in >/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
Not provided
| 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 Ophthalmic Ointment 0.5% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blocked arteries | Cardiac disorders | MedDRA | Systematic Assessment | One subject had 2 events of blocked arteries |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber inflammation | Eye disorders | MedDRA | Systematic Assessment | Ocular TEAEs Related to Study Drug in Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Trusso, MS. | Bausch & Lomb, Inc. | (585) 338-5561 | laura.trusso@bausch.com |
Not provided
| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle of Ophthalmic Loteprednol Etabonate | Drug | Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days. |
|
| At each visit: Visit 4-7, postoperative days 3-18 |
| Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. | Postoperative Day 3-18 (Each follow-up Visit 4-7) |
| Protocol Violation |
|
| Travel Problem |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Vehicle of Ophthalmic Loteprednol Etabonate |
|
|
| Primary | Participants With Grade 0 (no) Pain | Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe | Intent to treat population | Posted | Number | participants | Postoperative day 8 (Visit 5) |
|
|
|
| Secondary | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. | Intent to treat population | Posted | Number | participants | At each visit: Visit 4-7, postoperative days 3-18 |
|
|
|
| Secondary | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. | Intent to treat population. | Posted | Mean | Standard Deviation | Composite scores | Postoperative Day 3-18 (Each follow-up Visit 4-7) |
|
|
|
| 2 |
| 204 |
| 81 |
| 204 |
| EG001 | Vehicle | Vehicle of Ophthalmic Loteprednol Etabonate | 4 | 201 | 151 | 201 |
|
| Diabetic foot ulcer | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Fall/Hip fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pituitary tumor | Endocrine disorders | MedDRA | Systematic Assessment |
|
|
| Eye Pain | Eye disorders | MedDRA | Systematic Assessment | Ocular TEAEs >/= 5% in Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population |
|
| Corneal Edema | Eye disorders | MedDRA | Systematic Assessment | Ocular TEAEs in >/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population |
|
| Conjunctival Hyperemia | Eye disorders | MedDRA | Systematic Assessment | Ocular TEAEs in >/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population |
|
| Ciliary Hyperemia | Eye disorders | MedDRA | Systematic Assessment | Ocular TEAEs in >/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population |
|
| Photophobia | Eye disorders | MedDRA | Systematic Assessment | Ocular TEAEs in >/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population |
|
| Iritis | Eye disorders | MedDRA | Systematic Assessment | Ocular TEAEs in >/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population |
|
| Uveitis | Eye disorders | MedDRA | Systematic Assessment | Ocular TEAEs in >/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population |
|
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. Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee for comment.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Visit 6, posoperative day 15 |
|
| Visit 7, postoperative day 18 |
|
| Visit 6, postoperative day 15 |
|
| Visit 7, postoperative day 18 |
|