Status:
COMPLETED
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects
Lead Sponsor:
Innovative Medical
Conditions:
Cataract
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
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 inflamma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00469690
Start Date
May 1 2007
End Date
May 1 2008
Last Update
May 20 2008
Active Locations (1)
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1
Bucci Laser Vision Institute and Ambulatory Surgery Center
Wilkes-Barre, Pennsylvania, United States, 18702