Cataract, Inflammation
Conditions
Keywords
Surgery
Brief summary
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.
Interventions
DRUGBOL-303242-X
Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules.
DRUGVehicle for BOL-303242-X
Medication instilled into the study eye, subjects randomized to various drug dose schedules.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent. * Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations. * Subjects who are candidates for cataract surgery. * Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening. * Subjects must be able and willing to comply with all treatment and follow- up procedures.
Exclusion criteria
* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components. * Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study. * Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 8 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 8 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1% Twice a Day BOL-303242-X ophthalmic suspension 1% Twice a Day | 60 |
| 2% Once a Day BOL-303242-X ophthalmic suspension 2% Once a Day | 28 |
| 2% Twice a Day BOL-303242-X ophthalmic suspension 2% Twice a Day | 28 |
| 2% Four Times a Day BOL-303242-X ophthalmic suspension 2% Four times a Day | 60 |
| 3% Once a Day BOL-303242-X ophthalmic suspension 3% Once a Day | 59 |
| 3% Twice a Day BOL-303242-X ophthalmic suspension 3% Twice a Day | 60 |
| 3% Four Times a Day BOL-303242-X ophthalmic suspension 3% Four times a Day | 60 |
| Vehicle Vehicle for BOL-303242-X ophthalmic suspension | 60 |
| Total | 415 |
Baseline characteristics
| Characteristic | 1% Twice a Day | 2% Once a Day | 2% Twice a Day | 2% Four Times a Day | 3% Once a Day | 3% Twice a Day | 3% Four Times a Day | Vehicle | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 12 | 67.9 years STANDARD_DEVIATION 10.9 | 68.9 years STANDARD_DEVIATION 10.5 | 69.5 years STANDARD_DEVIATION 7.1 | 68.2 years STANDARD_DEVIATION 10.8 | 67.3 years STANDARD_DEVIATION 10.7 | 68.5 years STANDARD_DEVIATION 10.3 | 67.1 years STANDARD_DEVIATION 10.8 | 67.8 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 33 Participants | 15 Participants | 15 Participants | 34 Participants | 30 Participants | 32 Participants | 31 Participants | 32 Participants | 222 Participants |
| Sex: Female, Male Male | 27 Participants | 13 Participants | 13 Participants | 26 Participants | 29 Participants | 28 Participants | 29 Participants | 28 Participants | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 60 | 20 / 28 | 7 / 28 | 18 / 60 | 11 / 59 | 25 / 60 | 21 / 60 | 37 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 28 | 0 / 28 | 0 / 60 | 1 / 59 | 1 / 60 | 0 / 60 | 0 / 60 |
Outcome results
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.
Time frame: 8 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% Twice a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 35 Participants |
| 2% Once a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 19 Participants |
| 2% Twice a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 15 Participants |
| 2% Four Times a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 47 Participants |
| 3% Once a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 42 Participants |
| 3% Twice a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 45 Participants |
| 3% Four Times a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 42 Participants |
| Vehicle | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 30 Participants |
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.
Time frame: 8 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% Twice a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 15 Participants |
| 2% Once a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 6 Participants |
| 2% Twice a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 7 Participants |
| 2% Four Times a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 18 Participants |
| 3% Once a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 21 Participants |
| 3% Twice a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 23 Participants |
| 3% Four Times a Day | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 18 Participants |
| Vehicle | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 11 Participants |