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Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
This study has been completed.
Sponsored by: Innovative Medical
Information provided by: Innovative Medical
ClinicalTrials.gov Identifier: NCT00347503
  Purpose

Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition in human patients.


Condition Intervention Phase
Cataract
Drug: ketorolac 0.4%, bromfenac 0.09%
Phase IV

MedlinePlus related topics: Cataract
Drug Information available for: Ketorolac Ketorolac tromethamine Bromfenac Bromfenac sodium Dinoprostone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title: Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy Male/Female 21 years of age of older.
  • Patient understands and is willing to sign the written informed consent form
  • Likely to complete the entire course of the study.
  • Patient is scheduled to undergo cataract surgery
  • 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).
  • Patient is willing and able to administer eye drops and record the times the drops were instilled

Exclusion Criteria:

  • Patient has been using a topical NSAID within 1 week of study entry
  • Patient has a known sensitivity to any of the ingredients in the study medications
  • Patient has sight in only one eye
  • Patient has a history of previous intraocular surgery
  • 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
  • Female patients who are pregnant, nursing an infant or planning a pregnancy
  • 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: NCT00347503

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

Study ID Numbers: B2601
Study First Received: June 29, 2006
Last Updated: July 12, 2007
ClinicalTrials.gov Identifier: NCT00347503  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Dinoprostone
Bromfenac
Eye Diseases
Cataract
Ketorolac
Lens Diseases
Ketorolac Tromethamine

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

ClinicalTrials.gov processed this record on January 14, 2009