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

NCT ID: NCT00402493

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-03-31

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.

Conditions

Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ibuprofen, latanoprost, brimonidine

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

ibuprofen, latanoprost, brimonidine

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

ibuprofen, latanoprost, brimonidine

Intervention Type: DRUG

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

Intervention Type: DRUG

ibuprofen 200mg

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Ibuprofen

ibuprofen 200mg

Intervention Type: DRUG

Other Intervention Names

placebo; ibuprofen 200mg, and placebo pills; ibuprofen 200mg

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Philadelphia Eye Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph I. Markoff, Ph.D,M.D

Role: PRINCIPAL_INVESTIGATOR

Philadelphia Eye Associates

Locations

Philadelphia Eye Associates

Willingboro, New Jersey, United States

Philadelphia Eye Associates

Philadelphia, Pennsylvania, United States

Philadelphia Eye Associates

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

GA6110HV

Identifier Type: -

Identifier Source: org_study_id