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

Sponsor

Philadelphia Eye Associates (Other)

Overall Status

Completed

CT.gov ID

NCT00402493

Collaborator

Pfizer (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Ocular Hypertension	Drug: ibuprofen, latanoprost, brimonidine Drug: Ibuprofen, brimonidine, latanoprost Drug: Ibuprofen	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (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.

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 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
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 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
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 Names: placebo Drug: Ibuprofen ibuprofen 200mg Other Names: ibuprofen 200mg

Arm

Intervention/Treatment

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 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

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 Names:

placebo

Drug: Ibuprofen, brimonidine, latanoprost

Other Names:

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 Names:

placebo

Drug: Ibuprofen

ibuprofen 200mg

Other Names:

ibuprofen 200mg

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Philadelphia Eye Associates	Willingboro	New Jersey	United States	08046
2	Philadelphia Eye Associates	Philadelphia	Pennsylvania	United States	19134
3	Philadelphia Eye Associates	Philadelphia	Pennsylvania	United States	19148