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

Allergan263 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

263

Conditions

Cataract Extraction

Interventions

ketorolac eye dropsDRUG

1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing cataract surgery Exclusion Criteria: * Uncontrolled ocular disease in cataract surgery eye

Locations (1)

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

Resolution of Post Operative Inflammation

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)

Time frame: Day 14

Secondary Outcomes

Ocular Pain

Measured on a scale of 0-4 (0 = none, 4 = intolerable)

Time frame: Day 1

Mean Pupil Area

Pupil area post-irrigation and aspiration

Time frame: Day 0

Data from ClinicalTrials.gov

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