Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
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
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
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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
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.- 793
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
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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
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 | |
susan.harris@bauschhealth.com |
- 793