Trial Outcomes & Findings for Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (NCT NCT01591655)

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

360 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 four times daily (QID) for 14 days	Vehicle The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Overall Study STARTED	240	120
Overall Study COMPLETED	168	57
Overall Study NOT COMPLETED	72	63

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=240 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 Participants The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.	Total n=360 Participants Total of all reporting groups
Age, Continuous	67.1 years STANDARD_DEVIATION 10.27 • n=5 Participants	67.4 years STANDARD_DEVIATION 8.59 • n=7 Participants	67.2 years STANDARD_DEVIATION 9.73 • n=5 Participants
Sex: Female, Male Female	137 Participants n=5 Participants	67 Participants n=7 Participants	204 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	53 Participants n=7 Participants	156 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=240 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 Participants The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells	38 Participants	13 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=240 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 Participants The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Grade 0 Pain	172 Participants	59 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=240 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 Participants The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	71 Participants	21 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=240 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 Participants The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Grade 0 Pain	174 Participants	53 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=240 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 Participants The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.	152 Participants	46 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=240 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 Participants The vehicle of the mapracorat ophthalmic suspension Vehicle: 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.	67 Participants	21 Participants

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. 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=240 Participants Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 Participants The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Percentage of Treatment Failures	17 Participants	23 Participants

Adverse Events

Mapracorat

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mapracorat n=240 participants at risk Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 participants at risk The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Eye disorders Macular edema	0.42% 1/240 • 18 days	0.00% 0/120 • 18 days

Other adverse events

Other adverse events
Measure	Mapracorat n=240 participants at risk Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days	Vehicle n=120 participants at risk The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Eye disorders Eye pain	3.3% 8/240 • 18 days	5.8% 7/120 • 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