Cataract, Inflammation, Pain
Conditions
Brief summary
The objective of this 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.
Interventions
DRUGMapracorat
Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.
DRUGVehicle
Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
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 who are candidates for routine, uncomplicated cataract surgery. * Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.
Exclusion criteria
* Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery. * Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components. * Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 8 days | 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. |
| Percentage of Participants With Grade 0 Pain | 8 days | 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, where higher scores indicated worse pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mapracorat Mapracorat ophthalmic suspension
Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks. | 120 |
| Vehicle Vehicle of mapracorat ophthalmic suspension
Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks. | 57 |
| Total | 177 |
Baseline characteristics
| Characteristic | Mapracorat | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 66.5 years STANDARD_DEVIATION 9.72 | 63.2 years STANDARD_DEVIATION 12.29 | 65.4 years STANDARD_DEVIATION 10.69 |
| Sex: Female, Male Female | 75 Participants | 30 Participants | 105 Participants |
| Sex: Female, Male Male | 45 Participants | 27 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 120 | 6 / 57 |
| serious Total, serious adverse events | 0 / 120 | 0 / 57 |
Outcome results
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.
Time frame: 8 days
Population: Randomized participants were included without imputation of missing data at 8 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 9 Participants |
| Vehicle | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 6 Participants |
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, where higher scores indicated worse pain.
Time frame: 8 days
Population: Randomized participants were included without imputation of missing data at 8 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Grade 0 Pain | 65 Participants |
| Vehicle | Percentage of Participants With Grade 0 Pain | 27 Participants |