Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops

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ClinicalTrials.gov Identifier: NCT00402493

Recruitment Status : Completed

First Posted : November 22, 2006

Last Update Posted : April 4, 2018

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Philadelphia Eye Associates

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Glaucoma Ocular Hypertension	Drug: ibuprofen, latanoprost, brimonidine Drug: Ibuprofen, brimonidine, latanoprost Drug: Ibuprofen	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	51 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	A Prospective,Randomized,Masked,Study to Evaluate the Interaction of Non-Steroidal Anti-Inflammatory Agent With IOP-Lowering Effect of Brimonidine or Latanoprost.
Study Start Date :	December 2006
Actual Primary Completion Date :	March 2008
Actual Study Completion Date :	March 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Early-onset glaucoma Hypertension

MedlinePlus related topics: Glaucoma

Drug Information available for: Ibuprofen Ibuprofen sodium Ibuprofen lysine Brimonidine Brimonidine tartrate Midol Latanoprost

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Latanoprost to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure	Drug: ibuprofen, latanoprost, brimonidine to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure Other Name: placebo Drug: Ibuprofen, brimonidine, latanoprost to determine whether commonly used OTC non-steroidal anti-inflammatory agentsn(200mg ibuprofen) taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure Other Name: ibuprofen 200mg, and placebo pills
Active Comparator: Brimonidine to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure	Drug: ibuprofen, latanoprost, brimonidine to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure Other Name: placebo Drug: Ibuprofen, brimonidine, latanoprost to determine whether commonly used OTC non-steroidal anti-inflammatory agentsn(200mg ibuprofen) taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure Other Name: ibuprofen 200mg, and placebo pills
Active Comparator: ibuprofen to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure	Drug: ibuprofen, latanoprost, brimonidine to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure Other Name: placebo Drug: Ibuprofen ibuprofen 200mg Other Name: ibuprofen 200mg

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402493

Locations

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

Sponsors and Collaborators

Philadelphia Eye Associates

Pfizer

Investigators

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Principal Investigator:	Joseph I. Markoff, Ph.D,M.D	Philadelphia Eye Associates

More Information

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Responsible Party:	Philadelphia Eye Associates
ClinicalTrials.gov Identifier:	NCT00402493
Other Study ID Numbers:	GA6110HV
First Posted:	November 22, 2006 Key Record Dates
Last Update Posted:	April 4, 2018
Last Verified:	September 2017

Keywords provided by Philadelphia Eye Associates:


Glaucoma Ocular Hypertension Xalatan Alpahgan Ibuprofen	Non-Steroidal Anti-Inflammatory Brimonidine Latanoprost Eye Pressure Intra-Ocular Pressure

Additional relevant MeSH terms:

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Glaucoma Ocular Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Ibuprofen Brimonidine Tartrate Latanoprost Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Ophthalmic Solutions Pharmaceutical Solutions Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents

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