Phase 3
Completed N=360
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Cataract · Inflammation · Surgery
Source: ClinicalTrials.gov NCT01591655 ↗
Enrolled (actual)
360
Serious AEs
0.3%
Results posted
Sep 2020
Primary outcomePrimary: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells — 38; 13 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells |
38; 13 | — |
| PRIMARY Percentage of Participants With Grade 0 Pain |
174; 53 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. |
71; 21 | — |
| SECONDARY Percentage of Participants With Grade 0 Pain |
174; 53 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. |
152; 46 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare. |
67; 21 | — |
| SECONDARY Percentage of Treatment Failures |
17; 23 | — |
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 (NCT01591655). 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. Informational only — not medical advice.