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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.
Information provided by:
Innovative Medical Identifier:
First received: June 29, 2006
Last updated: July 12, 2007
Last verified: July 2007
Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition in human patients.

Condition Intervention Phase
Drug: ketorolac 0.4%, bromfenac 0.09%
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Innovative Medical:


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00347503

United States, Pennsylvania
Bucci Laser Vision
Wilkes Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Innovative Medical
Principal Investigator: Frank Bucci Bucci Vision Center
  More Information Identifier: NCT00347503     History of Changes
Other Study ID Numbers: B2601
Study First Received: June 29, 2006
Last Updated: July 12, 2007

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on May 22, 2017