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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347503
• Other study ID #: B2601
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2006
• Last updated: July 12, 2007

Study information

• Verified date: July 2007
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• ketorolac 0.4%, bromfenac 0.09%

Locations

Country	Name	City	State
United States	Bucci Laser Vision	Wilkes Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States,