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Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

NCT ID: NCT00791323

Last Updated: 2011-09-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-08-31

Brief Summary

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A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy

Detailed Description

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Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Ketorolac 0.4%

Group Type ACTIVE_COMPARATOR

Ketorolac 0.4%

Intervention Type DRUG

One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days

2

Mineral Oil Emollient

Group Type ACTIVE_COMPARATOR

Lubricating Eye Drop

Intervention Type DRUG

One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation

Interventions

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Ketorolac 0.4%

One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days

Intervention Type DRUG

Lubricating Eye Drop

One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation

Intervention Type DRUG

Other Intervention Names

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Acular LS™ Soothe® XP

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria

* History of intraocular surgery in the operative 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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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MA-ACU-08-001

Identifier Type: -

Identifier Source: org_study_id