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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01591161
Collaborator
(none)
369
Enrollment
1
Location
2
Arms
12
Duration (Months)
30.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
369 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

ArmIntervention/Treatment
Experimental: Mapracorat

Mapracorat ophthalmic suspension, 3%,

Drug: Mapracorat
1 drop of study medication into the study eye QID for 14 days

Placebo Comparator: Vehicle

The vehicle of the mapracorat ophthalmic suspension

Drug: Placebo
1 drop of vehicle into the study eye QID for 14 days.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Bausch & Lomb IncorporatedRochesterNew YorkUnited States14609

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Quintus Ngumah, OD, PhD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01591161
Other Study ID Numbers:
  • 790
First Posted:
May 3, 2012
Last Update Posted:
Sep 3, 2020
Last Verified:
Aug 1, 2020
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Period Title: Overall Study
STARTED245124
COMPLETED17468
NOT COMPLETED7156

Baseline Characteristics

Arm/Group TitleMapracoratVehicleTotal
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.Total of all reporting groups
Overall Participants245124369
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
69.0
(8.38)
68.1
(10.14)
68.7
(9.01)
Sex: Female, Male (Count of Participants)
Female
148
60.4%
72
58.1%
220
59.6%
Male
97
39.6%
52
41.9%
149
40.4%

Outcome Measures

1. Primary Outcome
TitlePercentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
DescriptionAnterior 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 Frame8 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants245124
Count of Participants [Participants]
49
20%
15
12.1%
2. Primary Outcome
TitlePercentage of Participants With Grade 0 Pain
DescriptionOcular 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 Frame8 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants245124
Count of Participants [Participants]
165
67.3%
65
52.4%
3. Secondary Outcome
TitlePercentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
DescriptionAnterior 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 Frame15 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants245124
Count of Participants [Participants]
87
35.5%
30
24.2%
4. Secondary Outcome
TitlePercentage of Participants With Grade 0 Pain
DescriptionOcular 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 Frame15 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants245124
Count of Participants [Participants]
170
69.4%
55
44.4%
5. Secondary Outcome
TitlePercentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
DescriptionA 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 Frame15 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants245124
Count of Participants [Participants]
165
67.3%
52
41.9%
6. Secondary Outcome
TitlePercentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare.
DescriptionAnterior 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 Frame15 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants245124
Count of Participants [Participants]
86
35.1%
29
23.4%
7. Secondary Outcome
TitleChange From Baseline Anterior Chamber (AC) Cells and Flare Combined
DescriptionAnterior 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 Frame15 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants245124
Mean (Standard Deviation) [score on a scale]
-2.2
(1.34)
-2.0
(1.45)
8. Secondary Outcome
TitlePercentage of Treatment Failures
DescriptionTreatment 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 Frame8 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants245124
Count of Participants [Participants]
10
4.1%
12
9.7%

Adverse Events

Time Frame18 days
Adverse Event Reporting Description
Arm/Group TitleMapracoratVehicle
Arm/Group DescriptionMapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye QID for 14 daysThe vehicle of the mapracorat ophthalmic suspension Placebo: 1 drop of vehicle into the study eye QID for 14 days.
All Cause Mortality
MapracoratVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
MapracoratVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/245 (0.8%) 0/124 (0%)
Eye disorders
Cystoid macular edema1/245 (0.4%) 0/124 (0%)
Gastrointestinal disorders
Colitis1/245 (0.4%) 0/124 (0%)
Other (Not Including Serious) Adverse Events
MapracoratVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/245 (0%) 0/124 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.

Results Point of Contact

Name/TitleStudy Director
OrganizationBausch Health
Phone
Emailsusan.harris@bauschhealth.com
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01591161
Other Study ID Numbers:
  • 790
First Posted:
May 3, 2012
Last Update Posted:
Sep 3, 2020
Last Verified:
Aug 1, 2020