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

Philadelphia Eye Associates

Status: Completed

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Ibuprofen; Drug: Ibuprofen, brimonidine, latanoprost; Drug: ibuprofen, latanoprost, brimonidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00402493

GA6110HV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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51 participants in 3 patient groups

Latanoprost

Active Comparator group

Description:

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

Treatment:

Drug: Ibuprofen, brimonidine, latanoprost

Drug: ibuprofen, latanoprost, brimonidine

Brimonidine

Active Comparator group

Description:

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

Treatment:

Drug: Ibuprofen, brimonidine, latanoprost

Drug: ibuprofen, latanoprost, brimonidine

ibuprofen

Active Comparator group

Description:

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

Treatment:

Drug: ibuprofen, latanoprost, brimonidine

Drug: Ibuprofen