Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery
Study Details
Study Description
Brief Summary
The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mapracorat Mapracorat ophthalmic suspension |
Drug: Mapracorat
Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.
Other Names:
|
| Placebo Comparator: Vehicle Vehicle of mapracorat ophthalmic suspension |
Drug: Vehicle
Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
|
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects who are candidates for routine, uncomplicated cataract surgery.
-
Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.
Exclusion Criteria:
-
Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
-
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
-
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.
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: Rabia Ozden, MD, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 664
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Mapracorat | Vehicle |
|---|---|---|
| Arm/Group Description | Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks. | Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks. |
| Period Title: Overall Study | ||
| STARTED | 120 | 57 |
| COMPLETED | 77 | 31 |
| NOT COMPLETED | 43 | 26 |
Baseline Characteristics
| Arm/Group Title | Mapracorat | Vehicle | Total |
|---|---|---|---|
| Arm/Group Description | Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks. | Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks. | Total of all reporting groups |
| Overall Participants | 120 | 57 | 177 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
66.5
(9.72)
|
63.2
(12.29)
|
65.4
(10.69)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
75
62.5%
|
30
52.6%
|
105
59.3%
|
| Male |
45
37.5%
|
27
47.4%
|
72
40.7%
|
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 |
|---|
| Randomized participants were included without imputation of missing data at 8 days. |
| Arm/Group Title | Mapracorat | Vehicle |
|---|---|---|
| Arm/Group Description | Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks. | Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks. |
| Measure Participants | 114 | 54 |
| Count of Participants [Participants] |
9
7.5%
|
6
10.5%
|
| 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, where higher scores indicated worse pain. |
| Time Frame | 8 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants were included without imputation of missing data at 8 days. |
| Arm/Group Title | Mapracorat | Vehicle |
|---|---|---|
| Arm/Group Description | Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks. | Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks. |
| Measure Participants | 114 | 54 |
| Count of Participants [Participants] |
65
54.2%
|
27
47.4%
|
Adverse Events
| Time Frame | 18 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Mapracorat | Vehicle | ||
| Arm/Group Description | Mapracorat ophthalmic suspension Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks. | Vehicle of mapracorat ophthalmic suspension Vehicle: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks. | ||
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 | 0/120 (0%) | 0/57 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Mapracorat | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/120 (4.2%) | 6/57 (10.5%) | ||
| Eye disorders | ||||
| Eye pain | 5/120 (4.2%) | 6/57 (10.5%) | ||
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 |
- 664