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

Phase 4

Completed

• Conditions: Cataract
• Interventions: Drug: Acular, Xibrom

• Registration Number: NCT00469690
• Lead Sponsor: Innovative Medical

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 inflammation. The study will conclude on the day of your cataract surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-02
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-19
• Last Update Posted: 2008-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Healthy Male/Female 21 years of age of older.
2. Patient understands and is willing to sign the written informed consent form
3. Likely to complete the entire course of the study.
4. Patient is scheduled to undergo cataract surgery
5. 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).
6. Patient is willing and able to administer eye drops and record the times the drops were instilled

Exclusion Criteria

1. Patient has been using a topical NSAID within 1 week of study entry
2. Patient has a known sensitivity to any of the ingredients in the study medications
3. Patient has sight in only one eye
4. Patient has a history of previous intraocular surgery
5. 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
6. Female patients who are pregnant, nursing an infant or planning a pregnancy
7. 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

Arm && Interventions

Group	Intervention	Description
1	Acular, Xibrom	-
2	Acular, Xibrom	-

Primary Outcome Measures

Name	Time	Method
Aqueous concentrations	8 months

Secondary Outcome Measures

Name	Time	Method
PGE2 Inhibition	8 months

Trial Locations

Locations (1)

Bucci Laser Vision Institute and Ambulatory Surgery Center; 🇺🇸 Wilkes Barre, Pennsylvania, United States