Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

Inflammation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791323
• Other study ID #: MA-ACU-08-001
• Status: Completed
• Phase: Phase 4
• First received: November 12, 2008
• Last updated: September 21, 2011
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

• History of intraocular surgery in the operative eye

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

Drug:
• Ketorolac 0.4%
One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
• Lubricating Eye Drop
One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels	The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).	Day 3	No