Phase 3
N=369
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Cataract · Inflammation · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01591161 ↗Enrolled (actual)
369
Serious AEs
0.5%
Results posted
Sep 2020
Primary outcome: Primary: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells — 49; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mapracorat (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells |
49; 15 | — |
| PRIMARY Percentage of Participants With Grade 0 Pain |
170; 55 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. |
87; 30 | — |
| SECONDARY Percentage of Participants With Grade 0 Pain |
170; 55 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. |
165; 52 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare. |
86; 29 | — |
| SECONDARY Change From Baseline Anterior Chamber (AC) Cells and Flare Combined |
-2.2; -2.0 | — |
| SECONDARY Percentage of Treatment Failures |
10; 12 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01591161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.