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

NCT ID: NCT00524264

Last Updated: 2009-10-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-04-30

Brief Summary

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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

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Conditions

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Cataract Extraction Pain Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

ketorolac

Intervention Type DRUG

Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.

Placebo

2

Group Type PLACEBO_COMPARATOR

ketorolac

Intervention Type DRUG

Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.

Placebo

Interventions

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ketorolac

Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing cataract surgery

Exclusion Criteria

* Uncontrolled ocular disease in cataract surgery eye
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan, Inc.

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Artesia, California, United States

Site Status

Countries

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United States

References

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Donnenfeld ED, Nichamin LD, Hardten DR, Raizman MB, Trattler W, Rajpal RK, Alpern LM, Felix C, Bradford RR, Villanueva L, Hollander DA, Schiffman RM. Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. Am J Ophthalmol. 2011 Mar;151(3):420-6.e1. doi: 10.1016/j.ajo.2010.09.003. Epub 2010 Dec 9.

Reference Type DERIVED
PMID: 21145532 (View on PubMed)

Related Links

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Other Identifiers

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191578-005

Identifier Type: -

Identifier Source: org_study_id

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