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

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.”

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.

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.

Intervention(s) in this Clinical Trial

• 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
• 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
• Drug: Ibuprofen
  • ibuprofen 200mg

Arms, Groups and Cohorts in this Clinical Trial

• 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
• 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
• 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

Primary Measures

• Intra-Ocular Pressure at Day 1
  • Time Frame: 10:00AM
    Safety Issue?: Yes
• Intra-Ocular Pressure at Day 14
  • Time Frame: 10:00AM
    Safety Issue?: Yes
• Intra-Ocular Pressure at Day 21
  • Time Frame: 10:00AM
    Safety Issue?: Yes
• Intra-Ocular Pressure at Day 28
  • Time Frame: 10:00AM
    Safety Issue?: Yes
• Intra-Ocular Pressure at Day 35
  • Time Frame: 10:00AM
    Safety Issue?: Yes
• Intra-Ocular Pressure at Day 49
  • Time Frame: 10:00AM
    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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Philadelphia Eye Associates Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00402493

Study ID Number: GA6110HV

ClinicalTrials.gov Identifier: NCT00402493

Health Authority: United States: Institutional Review Board