NCT00402493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 4, 2018

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

November 20, 2006

Last Update Submit

April 3, 2018

Conditions

GlaucomaOcular Hypertension

Keywords

GlaucomaOcular HypertensionXalatanAlpahganIbuprofenNon-Steroidal Anti-InflammatoryBrimonidineLatanoprostEye PressureIntra-Ocular Pressure

Study Arms (3)

Latanoprost

ACTIVE COMPARATOR

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

Drug: ibuprofen, latanoprost, brimonidineDrug: Ibuprofen, brimonidine, latanoprost

Brimonidine

ACTIVE COMPARATOR

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

Drug: ibuprofen, latanoprost, brimonidineDrug: Ibuprofen, brimonidine, latanoprost

ibuprofen

ACTIVE COMPARATOR

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

Drug: ibuprofen, latanoprost, brimonidineDrug: Ibuprofen

Interventions

ibuprofen, latanoprost, brimonidineDRUG

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

Also known as: placebo
BrimonidineLatanoprostibuprofen
Ibuprofen, brimonidine, latanoprostDRUG

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

Also known as: ibuprofen 200mg, and placebo pills
BrimonidineLatanoprost
IbuprofenDRUG

ibuprofen 200mg

Also known as: ibuprofen 200mg
ibuprofen

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Philadelphia Eye Associates

Willingboro, New Jersey, 08046, United States

Location

Philadelphia Eye Associates

Philadelphia, Pennsylvania, 19134, United States

Location

Philadelphia Eye Associates

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

IbuprofenLatanoprostBrimonidine Tartrate

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Joseph I. Markoff, Ph.D,M.D

    Philadelphia Eye Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

December 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 4, 2018

Record last verified: 2017-09

Locations

US(3)