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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:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00469690
First received: May 2, 2007
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  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 Blind (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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Aqueous concentrations [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PGE2 Inhibition [ Time Frame: 8 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 2, 2007
Last Updated: May 19, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013