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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.

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   

ChemIDplus related topics:   Ibuprofen    Dexibuprofen    Brimonidine    Brimonidine Tartrate    Latanoprost    Tetrahydrozoline    Tetrahydrozoline hydrochloride   

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


Study ID Numbers:   GA6110HV
First Received:   November 20, 2006
Last Updated:   January 31, 2008
ClinicalTrials.gov Identifier:   NCT00402493
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:
Ibuprofen
Glaucoma
Eye Diseases
Vascular Diseases
Tetrahydrozoline
Latanoprost
Brimonidine
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 03, 2008




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