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

Innovative Medical

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Drug: ketorolac 0.4%, bromfenac 0.09%

Study type

Interventional

Funder types

Industry

Identifiers

B2601

Details and patient eligibility

About

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

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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