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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
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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 related topics: Glaucoma

Arms and Interventions
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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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Information from the National Library of Medicine

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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
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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
Latanoprost
Brimonidine Tartrate
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
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents