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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovative Medical
• Treatments: Bromfenac; Ketorolac; Ketorolac Tromethamine

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