Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

September 21, 2011 updated by: Allergan
A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

  • History of intraocular surgery in the operative eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Ketorolac 0.4%
Drug: Ketorolac 0.4%
One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
Other Names:
  • Acular LS™
Active Comparator: 2
Mineral Oil Emollient
Drug: 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
Other Names:
  • Soothe® XP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels
Time Frame: Day 3
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Estimate)

September 23, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-ACU-08-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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