Cataract
Conditions
Keywords
Inflammation, Pain, Ocular surgery
Brief summary
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.
Interventions
DRUGMapracorat
Instill study medication into study eye per dosing instructions for 14 days
DRUGVehicle
Instill study medication into the study eye per dosing instructions for 14 days
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
* Participants who are candidates for routine, uncomplicated cataract surgery * Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye. * Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.
Exclusion criteria
* Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants. * Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids. * Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis). * Participants who have known hypersensitivity or contraindication to the study drug(s) or their components. * Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
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, were higher scores indicated worse pain. |
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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mapracorat Ophthalmic suspension 3%
Mapracorat: Instill study medication into study eye per dosing instructions for 14 days | 207 |
| Vehicle Vehicle of mapracorat ophthalmic suspension
Vehicle: Instill study medication into the study eye per dosing instructions for 14 days | 104 |
| Total | 311 |
Baseline characteristics
| Characteristic | Mapracorat | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 8.75 | 69.0 years STANDARD_DEVIATION 7.53 | 69.1 years STANDARD_DEVIATION 8.35 |
| Sex: Female, Male Female | 109 Participants | 58 Participants | 167 Participants |
| Sex: Female, Male Male | 98 Participants | 46 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 207 | 17 / 104 |
| serious Total, serious adverse events | 1 / 207 | 0 / 104 |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 32 Participants |
| Vehicle | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 12 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, were higher scores indicated worse pain.
Time frame: 8 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Grade 0 Pain | 130 Participants |
| Vehicle | Percentage of Participants With Grade 0 Pain | 57 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.
Time frame: 8 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 90 Participants |
| Vehicle | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 30 Participants |