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
To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. 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% ophthalmic ointment |
|
| Vehicle | Placebo Comparator | Vehicle of loteprednol etabonate ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% Loteprednol Etabonate Ophthalmic Ointment | Drug | 1/2 inch ribbon four times a day for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects 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) |
| Grade 0 for 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 |
|---|---|---|
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up 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 |
|---|---|---|
| Alyson J Berliner, MD/PhD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hunkeler, MD | Overland Park | Kansas | 66210 | United States |
Following cataract surgery at visit 3 (post operative day 1), subjects were assessed for eligibility. 201 subjects were randomized to receive loteprednol etabonate ointment and 199 to receive its vehicle.
A total of 400 subjects, 18 years old or older who were candidates for routine, uncomplicated cataract surgery, were enrolled at 17 investigative sites in the US. First subject was enrolled on 3/14/2008 and last subject visit was 3/23/2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol Etabonate | Loteprednol etabonate 0.5% ophthalmic ointment |
| FG001 | Vehicle | Vehicle of loteprednol etabonate ointment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle of Loteprednol Etabonate Ophthalmic Ointment | Drug | 1/2 inch ribbon four times a day for 14 days |
|
| At each follow-up visit through day18 (Visit 7) |
| 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. | Baseline and each follow-up visit through day18 (Visit 7) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol Etabonate | Loteprednol etabonate 0.5% ophthalmic ointment |
| BG001 | Vehicle | Vehicle of loteprednol etabonate ointment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 | Subjects 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 | Posted | Number | participants | Postoperative Day 8 (Visit 5) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up 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 follow-up visit through day18 (Visit 7) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Composit scores | Baseline and each follow-up visit through day18 (Visit 7) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Grade 0 for 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) |
|
|
The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
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 0.5% ophthalmic ointment | 3 | 201 | 110 | 201 | ||
| EG001 | Vehicle | Vehicle of loteprednol etabonate ointment | 2 | 199 | 161 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment | Unrelated to study drug but related to the cataract surgery. |
|
| Fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment | Unrelated to study drug and study participation, associated with an accidental injury. |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment | unrelated to study drug and study participation, due to a concurrent condition |
|
| Post-operative inflammation | Eye disorders | MedDRA (10.0) | Non-systematic Assessment | Corneal Macular Edema, possibley related to study drug, probably related to study participation. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber cell | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anterior chamber inflammation | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ciliary hyperemia | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Conjunctival hyperemia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Corneal edema | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ocular hyperemia | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Ocular pruritis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tuyen Ong | Bausch & Lomb | (973) 360-6389 | Tuyen.Ong@bausch.com |
| Male |
|
| Black or African American |
|
| White |
|
| Other |
|
|
|
|