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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ibuprofen, latanoprost, brimonidine
Ibuprofen, brimonidine, latanoprost
Ibuprofen
Sponsored by
Philadelphia Eye Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Ocular Hypertension, Xalatan, Alpahgan, Ibuprofen, Non-Steroidal Anti-Inflammatory, Brimonidine, Latanoprost, Eye Pressure, Intra-Ocular Pressure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Philadelphia Eye Associates
  • Philadelphia Eye Associates
  • Philadelphia Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Latanoprost

Brimonidine

ibuprofen

Arm 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

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 20, 2006
Last Updated
April 3, 2018
Sponsor
Philadelphia Eye Associates
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00402493
Brief Title
Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops
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 Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philadelphia Eye Associates
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Ocular Hypertension, Xalatan, Alpahgan, Ibuprofen, Non-Steroidal Anti-Inflammatory, Brimonidine, Latanoprost, Eye Pressure, Intra-Ocular Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Latanoprost
Arm Type
Active Comparator
Arm 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
Arm Title
Brimonidine
Arm Type
Active Comparator
Arm 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
Arm Title
ibuprofen
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
ibuprofen, latanoprost, brimonidine
Other Intervention Name(s)
placebo
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Ibuprofen, brimonidine, latanoprost
Other Intervention Name(s)
ibuprofen 200mg, and placebo pills
Intervention Description
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
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
ibuprofen 200mg
Intervention Description
ibuprofen 200mg

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph I. Markoff, Ph.D,M.D
Organizational Affiliation
Philadelphia Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia Eye Associates
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States

12. IPD Sharing Statement

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

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