Cataract, Inflammation, Surgery
Conditions
Brief summary
The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Interventions
DRUGMapracorat
1 drop of study medication into the study eye QID for 14 days
DRUGPlacebo
1 drop of vehicle into the study eye QID 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
* Subjects who are candidates for routine, uncomplicated cataract surgery. * Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye. * Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).
Exclusion criteria
* 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. * Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit. * Presence of active external ocular disease: infection or inflammation of the study eye. * Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components. * Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 15 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 was defined as Grade 0. |
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare. | 15 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. Anterior Chamber 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 was defined as Grade 0. |
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 15 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 Treatment Failures | 8 days | Treatment failure was defined as anterior chamber (AC) cell score worsened or remained the same, and the Investigator deemed it necessary to place the participant on rescue therapy. 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. 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. |
| Change From Baseline Anterior Chamber (AC) Cells and Flare Combined | 15 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. Anterior Chamber 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. The combined score could be at minimum 0 and at most 8, with higher scores indicating worse outcome. |
| Percentage of Participants With Grade 0 Pain | 15 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mapracorat Mapracorat ophthalmic suspension, 3%,
Mapracorat: 1 drop of study medication into the study eye QID for 14 days | 245 |
| Vehicle The vehicle of the mapracorat ophthalmic suspension
Placebo: 1 drop of vehicle into the study eye QID for 14 days. | 124 |
| Total | 369 |
Baseline characteristics
| Characteristic | Mapracorat | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 8.38 | 68.1 years STANDARD_DEVIATION 10.14 | 68.7 years STANDARD_DEVIATION 9.01 |
| Sex: Female, Male Female | 148 Participants | 72 Participants | 220 Participants |
| Sex: Female, Male Male | 97 Participants | 52 Participants | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 245 | 0 / 124 |
| serious Total, serious adverse events | 2 / 245 | 0 / 124 |
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 | 49 Participants |
| Vehicle | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells | 15 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Grade 0 Pain | 165 Participants |
| Vehicle | Percentage of Participants With Grade 0 Pain | 65 Participants |
Secondary
Change From Baseline Anterior Chamber (AC) Cells and Flare Combined
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. Anterior Chamber 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. The combined score could be at minimum 0 and at most 8, with higher scores indicating worse outcome.
Time frame: 15 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mapracorat | Change From Baseline Anterior Chamber (AC) Cells and Flare Combined | -2.2 score on a scale | Standard Deviation 1.34 |
| Vehicle | Change From Baseline Anterior Chamber (AC) Cells and Flare Combined | -2.0 score on a scale | Standard Deviation 1.45 |
Secondary
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: 15 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. | 87 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) Cells and Flare.
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. Anterior Chamber 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 was defined as Grade 0.
Time frame: 15 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare. | 86 Participants |
| Vehicle | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare. | 29 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 was defined as Grade 0.
Time frame: 15 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 165 Participants |
| Vehicle | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. | 52 Participants |
Secondary
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: 15 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapracorat | Percentage of Participants With Grade 0 Pain | 170 Participants |
| Vehicle | Percentage of Participants With Grade 0 Pain | 55 Participants |
Secondary
Percentage of Treatment Failures
Treatment failure was defined as anterior chamber (AC) cell score worsened or remained the same, and the Investigator deemed it necessary to place the participant on rescue therapy. 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. 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) |
|---|---|---|
| Mapracorat | Percentage of Treatment Failures | 10 Participants |
| Vehicle | Percentage of Treatment Failures | 12 Participants |