Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
Information source: Innovative Medical
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: ketorolac 0.4%, bromfenac 0.09% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Innovative Medical Official(s) and/or principal investigator(s):
Frank Bucci, Principal Investigator, Affiliation: Bucci Vision Center
Summary
Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition
in human patients.
Clinical Details
Official title: Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bucci Laser Vision, Wilkes Barre, Pennsylvania 18702, United States
Additional Information
Last updated: July 12, 2007
|
