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This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOL-303242-X | Experimental | BOL-303242-X (Mapracorat) |
|
| Vehicle | Placebo Comparator | Vehicle for BOL-303242-X (Mapracorat) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOL-303242-X | Drug | Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | Anterior chamber (AC) cells will be 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. Pigment cells and red blood cells are to be ignored. 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 |
| 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. Complete resolution of AC flare was defined as Grade 0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Trusso, MS | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% Twice a Day | BOL-303242-X ophthalmic suspension 1% Twice a Day |
| FG001 | 2% Once a Day | BOL-303242-X ophthalmic suspension 2% Once a Day |
| FG002 | 2% Twice a Day | BOL-303242-X ophthalmic suspension 2% Twice a Day |
| FG003 | 2% Four Times a Day | BOL-303242-X ophthalmic suspension 2% Four times a Day |
| FG004 | 3% Once a Day | BOL-303242-X ophthalmic suspension 3% Once a Day |
| FG005 | 3% Twice a Day | BOL-303242-X ophthalmic suspension 3% Twice a Day |
| FG006 | 3% Four Times a Day | BOL-303242-X ophthalmic suspension 3% Four times a Day |
| FG007 | Vehicle | Vehicle for BOL-303242-X ophthalmic suspension |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1% Twice a Day | BOL-303242-X ophthalmic suspension 1% Twice a Day |
| BG001 | 2% Once a Day | BOL-303242-X ophthalmic suspension 2% Once a Day |
| 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 | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | Anterior chamber (AC) cells will be 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. Pigment cells and red blood cells are to be ignored. 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 | 1% Twice a Day | BOL-303242-X ophthalmic suspension 1% Twice a Day |
| 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 |
|---|---|---|---|---|---|
| Headache | Nervous system 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 |
| 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 for BOL-303242-X | Drug | Medication instilled into the study eye, subjects randomized to various drug dose schedules. |
|
| 8 days |
| BG002 | 2% Twice a Day | BOL-303242-X ophthalmic suspension 2% Twice a Day |
| BG003 | 2% Four Times a Day | BOL-303242-X ophthalmic suspension 2% Four times a Day |
| BG004 | 3% Once a Day | BOL-303242-X ophthalmic suspension 3% Once a Day |
| BG005 | 3% Twice a Day | BOL-303242-X ophthalmic suspension 3% Twice a Day |
| BG006 | 3% Four Times a Day | BOL-303242-X ophthalmic suspension 3% Four times a Day |
| BG007 | Vehicle | Vehicle for BOL-303242-X ophthalmic suspension |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
BOL-303242-X ophthalmic suspension 2% Once a Day |
| OG002 | 2% Twice a Day | BOL-303242-X ophthalmic suspension 2% Twice a Day |
| OG003 | 2% Four Times a Day | BOL-303242-X ophthalmic suspension 2% Four times a Day |
| OG004 | 3% Once a Day | BOL-303242-X ophthalmic suspension 3% Once a Day |
| OG005 | 3% Twice a Day | BOL-303242-X ophthalmic suspension 3% Twice a Day |
| OG006 | 3% Four Times a Day | BOL-303242-X ophthalmic suspension 3% Four times a Day |
| OG007 | Vehicle | Vehicle for BOL-303242-X ophthalmic suspension |
|
|
| 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. Complete resolution of AC flare was defined as Grade 0. | Posted | Count of Participants | Participants | 8 days |
|
|
|
| 0 |
| 60 |
| 43 |
| 60 |
| EG001 | 2% Once a Day | BOL-303242-X ophthalmic suspension 2% Once a Day | 0 | 28 | 20 | 28 |
| EG002 | 2% Twice a Day | BOL-303242-X ophthalmic suspension 2% Twice a Day | 0 | 28 | 7 | 28 |
| EG003 | 2% Four Times a Day | BOL-303242-X ophthalmic suspension 2% Four times a Day | 0 | 60 | 18 | 60 |
| EG004 | 3% Once a Day | BOL-303242-X ophthalmic suspension 3% Once a Day | 1 | 59 | 11 | 59 |
| EG005 | 3% Twice a Day | BOL-303242-X ophthalmic suspension 3% Twice a Day | 1 | 60 | 25 | 60 |
| EG006 | 3% Four Times a Day | BOL-303242-X ophthalmic suspension 3% Four times a Day | 0 | 60 | 21 | 60 |
| EG007 | Vehicle | Vehicle for BOL-303242-X ophthalmic suspension | 0 | 60 | 37 | 60 |
| Subretinal neovascularization | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA | Non-systematic Assessment |
|
| AC Inflammation | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Corneal edema | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Eye pruritis | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Iritis | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Conjunctival hyperemia | Eye disorders | MedDRA | Non-systematic Assessment |
|
| AC Flare | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Ciliary hyperemia | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA | Non-systematic Assessment |
|
Contact sponsor directly for details.