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

Information source: Philadelphia Eye Associates
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: ibuprofen, latanoprost, brimonidine (Drug); Ibuprofen, brimonidine, latanoprost (Drug); Ibuprofen (Drug)

Phase: N/A

Status: Completed

Sponsored by: Philadelphia Eye Associates

Official(s) and/or principal investigator(s):
Joseph I. Markoff, Ph.D,M.D, Principal Investigator, Affiliation: Philadelphia Eye Associates


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome:

Intra-Ocular Pressure at Day 1

Intra-Ocular Pressure at Day 14

Intra-Ocular Pressure at Day 21

Intra-Ocular Pressure at Day 28

Intra-Ocular Pressure at Day 35

Intra-Ocular Pressure at Day 49

determine if commonly used OTC non-steroidal anti-inflammatory agent,ibuprofen has any effect on the ability of either brimonidine or latanoprost to lower high eye pressure.

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.


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients with bilateral or unilateral primary open angle glaucoma or ocular


- 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.

Locations and Contacts

Philadelphia Eye Associates, Willingboro, New Jersey 08046, United States

Philadelphia Eye Associates, Philadelphia, Pennsylvania 19134, United States

Philadelphia Eye Associates, Philadelphia, Pennsylvania 19148, United States

Additional Information

Starting date: December 2006
Last updated: December 4, 2012

Page last updated: August 23, 2015

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