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The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mapracorat | Experimental | Ophthalmic suspension 3% |
|
| Vehicle | Placebo Comparator | Vehicle of mapracorat ophthalmic suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mapracorat | Drug | Instill study medication into study eye per dosing instructions for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = >30 cells. Complete resolution of AC cells was defined as Grade 0. | 8 days |
| Percentage of Participants With Grade 0 Pain | Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, were higher scores indicated worse pain. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rabia Ozden, MD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Incorporated | Rochester | New York | 14609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mapracorat | Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days |
| FG001 | Vehicle | Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mapracorat | Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days |
| BG001 | Vehicle | Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = >30 cells. Complete resolution of AC cells was defined as Grade 0. | Posted | Count of Participants | Participants | 8 days |
|
18 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 | Mapracorat | Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid macular edema | Eye disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C546413 | R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol |
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| Vehicle | Drug | Instill study medication into the study eye per dosing instructions for 14 days |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days |
|
|
| Primary | Percentage of Participants With Grade 0 Pain | Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, were higher scores indicated worse pain. | Posted | Count of Participants | Participants | 8 days |
|
|
|
| Secondary | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. | Posted | Count of Participants | Participants | 8 days |
|
|
|
| 1 |
| 207 |
| 14 |
| 207 |
| EG001 | Vehicle | Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days | 0 | 104 | 17 | 104 |
| Corneal edema | Eye disorders | MedDRA | Non-systematic Assessment |
|
Contact sponsor directly for details.
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |