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
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.
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 1Intra-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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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.
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
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