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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00469690
First Posted: May 4, 2007
Last Update Posted: May 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Innovative Medical
  Purpose
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.

Condition Intervention Phase
Cataract Drug: Acular, Xibrom Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Aqueous concentrations [ Time Frame: 8 months ]

Secondary Outcome Measures:
  • PGE2 Inhibition [ Time Frame: 8 months ]

Enrollment: 58
Study Start Date: May 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: 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)
2 Drug: 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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469690


Locations
United States, Pennsylvania
Bucci Laser Vision Institute and Ambulatory Surgery Center
Wilkes Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Frank Bucci, MD Bucci Laser Vision Institute and Ambulatory Surgery Center
  More Information

Responsible Party: Frank Bucci, MD, Bucci Laser Vision Institute and Ambulatory Surgery Cneter
ClinicalTrials.gov Identifier: NCT00469690     History of Changes
Other Study ID Numbers: 5305
First Submitted: May 2, 2007
First Posted: May 4, 2007
Last Update Posted: May 20, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ketorolac
Bromfenac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action