Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients

Phase 4

Completed

• Conditions: Cataract

• Registration Number: NCT00347503
• Lead Sponsor: Innovative Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-29
• Study First Submitted QC: 2006-06-29
• Study First Posted: 2006-07-04
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-12
• Last Update Posted: 2007-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Bucci Laser Vision; 🇺🇸 Wilkes Barre, Pennsylvania, United States