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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

June 29, 2006
July 12, 2007
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Complete list of historical versions of study NCT00347503 on ClinicalTrials.gov Archive Site
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Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients

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

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Cataract
Drug: ketorolac 0.4%, bromfenac 0.09%
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00347503
B2601
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Innovative Medical
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Principal Investigator: Frank Bucci Bucci Vision Center
Innovative Medical
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP