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

Phase 3

Completed

• Conditions: Cataract Extraction
• Interventions: Drug: ketorolac eye drops

• Registration Number: NCT00521456
• Lead Sponsor: Allergan

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-23
• Study First Submitted QC: 2007-08-23
• Study First Posted: 2007-08-27
• Study Start: 2007-10
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-08
• Results First Submitted: 2009-08-19
• Results First Submitted QC: 2009-09-29
• Disposition First Submitted: 2009-09-29
• Disposition First Submitted QC: 2009-09-29
• Last Update Submitted: 2009-09-29
• Results First Posted: 2009-10-01
• Disposition First Posted: 2009-10-01
• Last Update Posted: 2009-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

• Patients undergoing cataract surgery

Exclusion Criteria

• Uncontrolled ocular disease in cataract surgery eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ketorolac eye drops	-
1	ketorolac eye drops	-

Primary Outcome Measures

Name	Time	Method
Resolution of Post Operative Inflammation	Day 14	Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \>50 cells)

Secondary Outcome Measures

Name	Time	Method
Ocular Pain	Day 1	Measured on a scale of 0-4 (0 = none, 4 = intolerable)
Mean Pupil Area	Day 0	Pupil area post-irrigation and aspiration