Phase 3
Completed N=311
Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery
Source: ClinicalTrials.gov NCT01230125 ↗Enrolled (actual)
311
Serious AEs
0.3%
Results posted
Sep 2020
Primary outcomePrimary: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. — 32; 12 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 This can indicate results are unpublished — a known publication-bias signal.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% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. |
32; 12 | — |
| PRIMARY Percentage of Participants With Grade 0 Pain |
130; 57 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. |
90; 30 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01230125). 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.