Trial Outcomes & Findings for Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery (NCT NCT01298752)

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

TERMINATED

Study phase

PHASE3

Target enrollment

177 participants

Primary outcome timeframe

8 days

Results posted on

2020-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Mapracorat Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.	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.
Overall Study STARTED	120	57
Overall Study COMPLETED	77	31
Overall Study NOT COMPLETED	43	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mapracorat n=120 Participants Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.	Vehicle n=57 Participants Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.	Total n=177 Participants Total of all reporting groups
Age, Continuous	66.5 years STANDARD_DEVIATION 9.72 • n=93 Participants	63.2 years STANDARD_DEVIATION 12.29 • n=4 Participants	65.4 years STANDARD_DEVIATION 10.69 • n=27 Participants
Sex: Female, Male Female	75 Participants n=93 Participants	30 Participants n=4 Participants	105 Participants n=27 Participants
Sex: Female, Male Male	45 Participants n=93 Participants	27 Participants n=4 Participants	72 Participants n=27 Participants

PRIMARY outcome

Timeframe: 8 days

Population: Randomized participants were included without imputation of missing data at 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=114 Participants Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.	Vehicle n=54 Participants Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	9 Participants	6 Participants

PRIMARY outcome

Timeframe: 8 days

Population: Randomized participants were included without imputation of missing data at 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=114 Participants Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.	Vehicle n=54 Participants Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
Percentage of Participants With Grade 0 Pain	65 Participants	27 Participants

Adverse Events

Mapracorat

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mapracorat n=120 participants at risk Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.	Vehicle n=57 participants at risk Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
Eye disorders Eye pain	4.2% 5/120 • 18 days	10.5% 6/57 • 18 days

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