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Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects

NCT ID: NCT00469690

Last Updated: 2008-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to compare the ability of two different topical NSAIDs (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the eye and to stop inflammation. The study will conclude on the day of your cataract surgery.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type OTHER

Acular, Xibrom

Intervention Type DRUG

1. Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am)
2. Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm)

2

Group Type OTHER

Acular, Xibrom

Intervention Type DRUG

1. Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am)
2. Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm)

Interventions

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Acular, Xibrom

1. Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am)
2. Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy Male/Female 21 years of age of older.
2. Patient understands and is willing to sign the written informed consent form
3. Likely to complete the entire course of the study.
4. Patient is scheduled to undergo cataract surgery
5. Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
6. Patient is willing and able to administer eye drops and record the times the drops were instilled

Exclusion Criteria

1. Patient has been using a topical NSAID within 1 week of study entry
2. Patient has a known sensitivity to any of the ingredients in the study medications
3. Patient has sight in only one eye
4. Patient has a history of previous intraocular surgery
5. Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study
6. Female patients who are pregnant, nursing an infant or planning a pregnancy
7. Patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Bucci Laser Vision Institute and Ambulatory Surgery Cneter

Principal Investigators

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Frank Bucci, MD

Role: PRINCIPAL_INVESTIGATOR

Bucci Laser Vision Institute and Ambulatory Surgery Center

Locations

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Bucci Laser Vision Institute and Ambulatory Surgery Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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5305

Identifier Type: -

Identifier Source: org_study_id