Trial Outcomes & Findings for Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (NCT NCT01591161)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

369 participants

Primary outcome timeframe

8 days

Results posted on

2020-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Mapracorat Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Overall Study STARTED	245	124
Overall Study COMPLETED	174	68
Overall Study NOT COMPLETED	71	56

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mapracorat n=245 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 Participants The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.	Total n=369 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 8.38 • n=5 Participants	68.1 years STANDARD_DEVIATION 10.14 • n=7 Participants	68.7 years STANDARD_DEVIATION 9.01 • n=5 Participants
Sex: Female, Male Female	148 Participants n=5 Participants	72 Participants n=7 Participants	220 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	52 Participants n=7 Participants	149 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mapracorat n=245 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 Participants The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells	49 Participants	15 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mapracorat n=245 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 Participants The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Grade 0 Pain	165 Participants	65 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mapracorat n=245 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 Participants The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	87 Participants	30 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mapracorat n=245 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 Participants The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Grade 0 Pain	170 Participants	55 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mapracorat n=245 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 Participants The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.	165 Participants	52 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mapracorat n=245 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 Participants The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare.	86 Participants	29 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mapracorat n=245 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 Participants The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Change From Baseline Anterior Chamber (AC) Cells and Flare Combined	-2.2 score on a scale Standard Deviation 1.34	-2.0 score on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mapracorat n=245 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 Participants The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Treatment Failures	10 Participants	12 Participants

Adverse Events

Mapracorat

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mapracorat n=245 participants at risk Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 days	Vehicle n=124 participants at risk The vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Eye disorders Cystoid macular edema	0.41% 1/245 • 18 days	0.00% 0/124 • 18 days
Gastrointestinal disorders Colitis	0.41% 1/245 • 18 days	0.00% 0/124 • 18 days

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Bausch Health

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER