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
NCT01591655
Collaborator
(none)
360
1
2
15
24

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. Participants from the United States and Canada will be recruited for this study.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
360 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 :
Sep 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mapracorat

Mapracorat ophthalmic suspension, 3%,

Drug: Mapracorat
1 drop of study medication into the study eye four times daily (QID) for 14 days

Placebo Comparator: Vehicle

The vehicle of the mapracorat ophthalmic suspension

Drug: Vehicle
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. 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. 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

Site City State Country Postal Code
1 Bausch & Lomb, Incorporated Rochester New York United States 14609

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:
NCT01591655
Other Study ID Numbers:
  • 793
First Posted:
May 4, 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 Title Mapracorat Vehicle
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Period Title: Overall Study
STARTED 240 120
COMPLETED 168 57
NOT COMPLETED 72 63

Baseline Characteristics

Arm/Group Title Mapracorat Vehicle Total
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days. Total of all reporting groups
Overall Participants 240 120 360
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
67.1
(10.27)
67.4
(8.59)
67.2
(9.73)
Sex: Female, Male (Count of Participants)
Female
137
57.1%
67
55.8%
204
56.7%
Male
103
42.9%
53
44.2%
156
43.3%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
Description 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.
Time Frame 8 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mapracorat Vehicle
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants 240 120
Count of Participants [Participants]
38
15.8%
13
10.8%
2. Primary Outcome
Title Percentage of Participants With Grade 0 Pain
Description 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.
Time Frame 8 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mapracorat Vehicle
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants 240 120
Count of Participants [Participants]
172
71.7%
59
49.2%
3. Secondary Outcome
Title Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
Description 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.
Time Frame 15 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mapracorat Vehicle
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants 240 120
Count of Participants [Participants]
71
29.6%
21
17.5%
4. Secondary Outcome
Title Percentage of Participants With Grade 0 Pain
Description 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.
Time Frame 15 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mapracorat Vehicle
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants 240 120
Count of Participants [Participants]
174
72.5%
53
44.2%
5. Secondary Outcome
Title Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
Description 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 Frame 15 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mapracorat Vehicle
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants 240 120
Count of Participants [Participants]
152
63.3%
46
38.3%
6. Secondary Outcome
Title Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare.
Description 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.
Time Frame 15 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mapracorat Vehicle
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants 240 120
Count of Participants [Participants]
67
27.9%
21
17.5%
7. Secondary Outcome
Title Percentage of Treatment Failures
Description 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.
Time Frame 8 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mapracorat Vehicle
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
Measure Participants 240 120
Count of Participants [Participants]
17
7.1%
23
19.2%

Adverse Events

Time Frame 18 days
Adverse Event Reporting Description
Arm/Group Title Mapracorat Vehicle
Arm/Group Description Mapracorat ophthalmic suspension, 3%, Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days The vehicle of the mapracorat ophthalmic suspension Vehicle: 1 drop of vehicle into the study eye QID for 14 days.
All Cause Mortality
Mapracorat Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Mapracorat Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/240 (0.4%) 0/120 (0%)
Eye disorders
Macular edema 1/240 (0.4%) 0/120 (0%)
Other (Not Including Serious) Adverse Events
Mapracorat Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 8/240 (3.3%) 7/120 (5.8%)
Eye disorders
Eye pain 8/240 (3.3%) 7/120 (5.8%)

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/Title Study Director
Organization Bausch Health
Phone
Email susan.harris@bauschhealth.com
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01591655
Other Study ID Numbers:
  • 793
First Posted:
May 4, 2012
Last Update Posted:
Sep 3, 2020
Last Verified:
Aug 1, 2020