Phase 4
N=64
Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00870103 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. — 91.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. |
91.7 | — |
| PRIMARY The Percentage of Patients With no Ocular Pain |
96.7 | — |
Summary
To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.
Eligibility Criteria
Inclusion Criteria
- ≧18 years of age
- able to sign an informed consent and complete all required visits
- intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL)
- Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)
Exclusion Criteria
- Uncontrolled glaucoma or IOP
- use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye
- use of steroid during the study or within 14 days prior to enrollment
Data sourced from ClinicalTrials.gov (NCT00870103). 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.