Clinical trial NCT00402493: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular Hypertension
Xalatan
Alpahgan
Ibuprofen
Non-Steroidal Anti-Inflammatory
Brimonidine
Latanoprost
Eye Pressure
Intra-Ocular Pressure
Lead sponsor: Philadelphia Eye Associates
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-11-22
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Willingboro
country: United States
facility: Philadelphia Eye Associates
state: New Jersey
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
Study officials:
affiliation: Philadelphia Eye Associates
name: Joseph I. Markoff, Ph.D,M.D
role: PRINCIPAL_INVESTIGATOR
References: