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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.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00347503
First received: June 29, 2006
Last updated: July 12, 2007
Last verified: July 2007
  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 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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on November 20, 2014