Phase 3 N=248 Randomized Double-blind Treatment

A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

Cataract Extraction · Pain · Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT00524264 ↗

Enrolled (actual)

248

Serious AEs

—

Results posted

Oct 2009

Primary outcome: Primary: Resolution of Post Operative Inflammation — 46.3; 25.6 % of participants with a score of 0

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ketorolac (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Resolution of Post Operative Inflammation	46.3; 25.6	—
SECONDARY Ocular Pain	75.0; 41.0	—
SECONDARY Mean Pupil Area	41.8; 41.1	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00524264). 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.