Trial Outcomes & Findings for Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery (NCT NCT01230125)

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

311 participants

Primary outcome timeframe

8 days

Results posted on

2020-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Mapracorat Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days	Vehicle Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days
Overall Study STARTED	207	104
Overall Study COMPLETED	134	54
Overall Study NOT COMPLETED	73	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mapracorat n=207 Participants Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days	Vehicle n=104 Participants Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days	Total n=311 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 8.75 • n=5 Participants	69.0 years STANDARD_DEVIATION 7.53 • n=7 Participants	69.1 years STANDARD_DEVIATION 8.35 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	58 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	46 Participants n=7 Participants	144 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=207 Participants Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days	Vehicle n=104 Participants Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	32 Participants	12 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, were higher scores indicated worse pain.

Outcome measures

Outcome measures
Measure	Mapracorat n=207 Participants Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days	Vehicle n=104 Participants Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days
Percentage of Participants With Grade 0 Pain	130 Participants	57 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mapracorat n=207 Participants Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days	Vehicle n=104 Participants Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.	90 Participants	30 Participants

Adverse Events

Mapracorat

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mapracorat n=207 participants at risk Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days	Vehicle n=104 participants at risk Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days
Eye disorders Cystoid macular edema	0.48% 1/207 • 18 days	0.00% 0/104 • 18 days

Other adverse events

Other adverse events
Measure	Mapracorat n=207 participants at risk Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days	Vehicle n=104 participants at risk Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days
Eye disorders Eye pain	4.3% 9/207 • 18 days	9.6% 10/104 • 18 days
Eye disorders Corneal edema	2.4% 5/207 • 18 days	6.7% 7/104 • 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