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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years and older (Adult, Senior)
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Philadelphia Eye Associates
ClinicalTrials.gov Identifier:	NCT00402493 History of Changes
Other Study ID Numbers:	GA6110HV
First Posted:	November 22, 2006
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:

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