Phase 3
N=263
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Cataract Extraction
Bottom Line
View on ClinicalTrials.gov: NCT00521456 ↗Enrolled (actual)
263
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Resolution of Post Operative Inflammation — 58.0; 27.3 % of participants with a score of 0
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ketorolac eye drops (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of Post Operative Inflammation |
58.0; 27.3 | — |
| SECONDARY Ocular Pain |
70.0; 38.5 | — |
| SECONDARY Mean Pupil Area |
37.9; 36.5 | — |
Summary
This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery
Eligibility Criteria
Inclusion Criteria
- Patients undergoing cataract surgery
Exclusion Criteria
- Uncontrolled ocular disease in cataract surgery eye
Data sourced from ClinicalTrials.gov (NCT00521456). 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.