Phase 2
N=415
Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
Cataract · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT00905450 ↗Enrolled (actual)
415
Serious AEs
0.5%
Results posted
Sep 2020
Primary outcome: Primary: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. — 35; 19; 15; 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BOL-303242-X (Drug); Vehicle for BOL-303242-X (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells. |
35; 19; 15; 47; 42; 45 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare. |
15; 6; 7; 18; 21; 23 | — |
Summary
This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery.
Eligibility Criteria
Inclusion Criteria
- Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent.
- Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
- Subjects who are candidates for cataract surgery.
- Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening.
- Subjects must be able and willing to comply with all treatment and follow- up procedures.
Exclusion Criteria
- Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
- Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
- Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Data sourced from ClinicalTrials.gov (NCT00905450). 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.