Back to resultsAqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acular, Xibrom
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility 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
Sites / Locations
- Bucci Laser Vision Institute and Ambulatory Surgery Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Aqueous concentrations
Secondary Outcome Measures
PGE2 Inhibition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00469690
Brief Title
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects
Official Title
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Innovative Medical
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Title
2
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Acular, Xibrom
Intervention Description
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)
Primary Outcome Measure Information:
Title
Aqueous concentrations
Time Frame
8 months
Secondary Outcome Measure Information:
Title
PGE2 Inhibition
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Bucci, MD
Organizational Affiliation
Bucci Laser Vision Institute and Ambulatory Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucci Laser Vision Institute and Ambulatory Surgery Center
City
Wilkes Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects
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