Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation 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% 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 Ophthalmic suspension 3% |
Drug: Mapracorat
Instill study medication into study eye per dosing instructions for 14 days
Other Names:
|
| Placebo Comparator: Vehicle Vehicle of mapracorat ophthalmic suspension |
Drug: Vehicle
Instill study medication into the study eye per dosing instructions 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, were higher scores indicated worse pain.
Secondary Outcome Measures
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. [8 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants who are candidates for routine, uncomplicated cataract surgery
-
Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
-
Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.
Exclusion Criteria:
-
Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.
-
Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.
-
Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).
-
Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.
-
Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
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.- 663
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Mapracorat | Vehicle |
|---|---|---|
| Arm/Group Description | Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days | Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days |
| Period Title: Overall Study | ||
| STARTED | 207 | 104 |
| COMPLETED | 134 | 54 |
| NOT COMPLETED | 73 | 50 |
Baseline Characteristics
| Arm/Group Title | Mapracorat | Vehicle | Total |
|---|---|---|---|
| Arm/Group Description | Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days | Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days | Total of all reporting groups |
| Overall Participants | 207 | 104 | 311 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
69.2
(8.75)
|
69.0
(7.53)
|
69.1
(8.35)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
109
52.7%
|
58
55.8%
|
167
53.7%
|
| Male |
98
47.3%
|
46
44.2%
|
144
46.3%
|
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 | Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days | Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days |
| Measure Participants | 207 | 104 |
| Count of Participants [Participants] |
32
15.5%
|
12
11.5%
|
| 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 | 8 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mapracorat | Vehicle |
|---|---|---|
| Arm/Group Description | Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days | Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days |
| Measure Participants | 207 | 104 |
| Count of Participants [Participants] |
130
62.8%
|
57
54.8%
|
| 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. |
| Time Frame | 8 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mapracorat | Vehicle |
|---|---|---|
| Arm/Group Description | Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days | Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions for 14 days |
| Measure Participants | 207 | 104 |
| Count of Participants [Participants] |
90
43.5%
|
30
28.8%
|
Adverse Events
| Time Frame | 18 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Mapracorat | Vehicle | ||
| Arm/Group Description | Ophthalmic suspension 3% Mapracorat: Instill study medication into study eye per dosing instructions for 14 days | Vehicle of mapracorat ophthalmic suspension Vehicle: Instill study medication into the study eye per dosing instructions 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 | 1/207 (0.5%) | 0/104 (0%) | ||
| Eye disorders | ||||
| Cystoid macular edema | 1/207 (0.5%) | 0/104 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Mapracorat | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/207 (6.8%) | 17/104 (16.3%) | ||
| Eye disorders | ||||
| Eye pain | 9/207 (4.3%) | 10/104 (9.6%) | ||
| Corneal edema | 5/207 (2.4%) | 7/104 (6.7%) | ||
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 |
- 663