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

Glaucoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402493
• Other study ID #: GA6110HV
• Status: Completed
• Phase: N/A
• First received: November 20, 2006
• Last updated: April 3, 2018
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: September 2017
• Source: Philadelphia Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

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
• 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
• Ibuprofen
ibuprofen 200mg

Locations

Country	Name	City	State
United States	Philadelphia Eye Associates	Philadelphia	Pennsylvania
United States	Philadelphia Eye Associates	Philadelphia	Pennsylvania
United States	Philadelphia Eye Associates	Willingboro	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Philadelphia Eye Associates	Pfizer

Country where clinical trial is conducted

United States,