Trial | NCT00402493  Report issue

Title

Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops
A Prospective,Randomized,Masked,Study to Evaluate the Interaction of Non-Steroidal Anti-Inflammatory Agent With IOP-Lowering Effect of Brimonidine or Latanoprost.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    51
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.
Study Started
Dec 31
2006
Primary Completion
Mar 31
2008
Study Completion
Mar 31
2008
Last Update
Apr 04
2018

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 names: 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 names: ibuprofen 200mg, and placebo pills

Drug Ibuprofen

ibuprofen 200mg

  • Other names: ibuprofen 200mg

Latanoprost Active Comparator

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

Brimonidine Active Comparator

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

ibuprofen Active Comparator

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

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.
No Results Posted