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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469690
• Other study ID #: 5305
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2007
• Last updated: May 19, 2008
• Start date: May 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Acular, Xibrom
Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am) Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm)

Locations

Country	Name	City	State
United States	Bucci Laser Vision Institute and Ambulatory Surgery Center	Wilkes Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aqueous concentrations		8 months	No
Secondary	PGE2 Inhibition		8 months	No