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

NCT00469690 | Completed Phase 4

• 1 other identifier: 5305
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Aqueous concentrations

  8 months

Secondary Outcomes (1)

• PGE2 Inhibition

  8 months

Study Arms (2)

1

OTHER

Drug: Acular, Xibrom

2

OTHER

Drug: Acular, Xibrom

Interventions

Acular, Xibrom DRUG

1. Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am) 2. Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm)

1; 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovative Medical: lead

Study Sites (1)

Bucci Laser Vision Institute and Ambulatory Surgery Center

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Ketorolac Tromethamine; bromfenac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Frank Bucci, MD

  Bucci Laser Vision Institute and Ambulatory Surgery Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 4, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

US (1)