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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Joseph I. Markoff, MD, Philadelphia Eye Associates
ClinicalTrials.gov Identifier:
NCT00402493
First received: November 20, 2006
Last updated: December 4, 2012
Last verified: December 2012
  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
Drug: Ibuprofen, brimonidine, latanoprost
Drug: Ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Philadelphia Eye Associates:

Primary Outcome Measures:
  • Intra-Ocular Pressure at Day 1 [ Time Frame: 10:00AM ] [ Designated as safety issue: Yes ]
  • Intra-Ocular Pressure at Day 14 [ Time Frame: 10:00AM ] [ Designated as safety issue: Yes ]
  • Intra-Ocular Pressure at Day 21 [ Time Frame: 10:00AM ] [ Designated as safety issue: Yes ]
  • Intra-Ocular Pressure at Day 28 [ Time Frame: 10:00AM ] [ Designated as safety issue: Yes ]
  • Intra-Ocular Pressure at Day 35 [ Time Frame: 10:00AM ] [ Designated as safety issue: Yes ]
  • Intra-Ocular Pressure at Day 49 [ Time Frame: 10:00AM ] [ Designated as safety issue: Yes ]
  • determine if commonly used OTC non-steroidal anti-inflammatory agent,ibuprofen has any effect on the ability of either brimonidine or latanoprost to lower high eye pressure. [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Joseph I. Markoff, MD, Ophthalmologist, Philadelphia Eye Associates
ClinicalTrials.gov Identifier: NCT00402493     History of Changes
Other Study ID Numbers: GA6110HV
Study First Received: November 20, 2006
Last Updated: December 4, 2012
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

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Brimonidine
Latanoprost
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 28, 2014