Study to Determine if Taking an Over The Counter Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Eye Drops for the Treatment of Glaucoma

This study has been completed.

First Received: November 20, 2006 Last Updated: January 31, 2008 History of Changes

Sponsors and Collaborators:	Philadelphia Eye Associates Pfizer
Information provided by:	Philadelphia Eye Associates
ClinicalTrials.gov Identifier:	NCT00402493

Purpose

The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.

Condition	Intervention
Glaucoma Ocular Hypertension	Drug: ibuprofen, latanoprost, brimonidine

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure Over-the-Counter Medicines

Drug Information available for: Ibuprofen Dexibuprofen Brimonidine Brimonidine tartrate Latanoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Prospective,Randomized,Masked,Study to Evaluate the Interaction of a Non-Steroidal Anti-Inflammatory Agent With the IOP-Lowering Effect of Brimonidine or Latanoprost.

Further study details as provided by Philadelphia Eye Associates:

Primary Outcome Measures:

Intra-Ocular Pressure at Day 1
Intra-Ocular Pressure at Day 14
Intra-Ocular Pressure at Day 21
Intra-Ocular Pressure at Day 28
Intra-Ocular Pressure at Day 35
Intra-Ocular Pressure at Day 49

Estimated Enrollment:	50
Study Start Date:	December 2006

Detailed Description:

Topical IOP-lowering therapy has the advantage of providing a drug level directly to the end organ with very little or no systemic absorption thereby reducing side effect potential. There is very little information in the ophthalmic literature regarding potential drug interactions between topical IOP-lowering medications and other medications taken orally for other medical reasons. Patients will be randomized to either latanoprost or brimonidine.

Patients in both groups will be randomized to either placebo or ibuprofen for the first 14 days and then crossed over to the other treatment for 14 days.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with bilateral or unilateral primary open angle glaucoma or ocular hypertension
An IOP in each eye of greater than 22mm HG after washout of IOP lowering medications
No worse than 20/200 best corrected visual acuity
Normal appearing or non-occludable anterior chamber angles
Discontinuation of current POAG or OH medications before participation in the study.
Written Informed Consent

Exclusion Criteria:

Use of any other ocular medications
Previous ocular surgery or laser therapy within the last three months.
Systemic treatment with any adrenergic agonist or antagonist, corticosteroid or nonsteroidal anti-inflammatory agents(low dose apsirin will be accepted if dose remains the same for entire study period).
An age of less than 21,of child bearing age and currently pregnant, considering pregnancy or a nursing mother.
A history of medical noncompliance or unreliability.
Presence of uncontrolled hypertension, cardiac arrhythmia, cerebrovascular accident, nasal polyps, bleeding diathesis, peptic ulcer disease, gastritis or known intolerance, contraindication or allergy to any drugs used in the study.
Lactose Intolerance.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402493

Locations

United States, New Jersey
Philadelphia Eye Associates
Willingboro, New Jersey, United States, 08046
United States, Pennsylvania
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States, 19148
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States, 19134

Sponsors and Collaborators

Philadelphia Eye Associates

Pfizer

Investigators

Principal Investigator:

Joseph I. Markoff, Ph.D,M.D

Philadelphia Eye Associates

More Information

No publications provided

Study ID Numbers:	GA6110HV
Study First Received:	November 20, 2006
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00402493 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Philadelphia Eye Associates:

Glaucoma
Ocular Hypertension
Xalatan
Alpahgan
Ibuprofen

Non-Steroidal Anti-Inflammatory
Brimonidine
Latanoprost
Eye Pressure
Intra-Ocular Pressure

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Ibuprofen
Adrenergic alpha-Agonists
Adrenergic Agents
Eye Diseases
Cyclooxygenase Inhibitors
Vascular Diseases
Cardiovascular Agents
Tetrahydrozoline
Antihypertensive Agents

Latanoprost
Adrenergic Agonists
Glaucoma
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Ocular Hypertension
Hypertension
Brimonidine

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Glaucoma
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Ibuprofen
Adrenergic alpha-Agonists
Eye Diseases

Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Latanoprost
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Brimonidine
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009