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

NCT00402493

Last updated date
Study Location
Philadelphia Eye Associates
Willingboro, New Jersey, 08046, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops
Official Title  ICMJE A Prospective,Randomized,Masked,Study to Evaluate the Interaction of Non-Steroidal Anti-Inflammatory Agent With IOP-Lowering Effect of Brimonidine or Latanoprost.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: 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
    Other Name: placebo
  • 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
    Other Name: ibuprofen 200mg, and placebo pills
  • Drug: Ibuprofen
    ibuprofen 200mg
    Other Name: ibuprofen 200mg
Study Arms  ICMJE
  • Active Comparator: 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
    Interventions:
    • Drug: ibuprofen, latanoprost, brimonidine
    • Drug: Ibuprofen, brimonidine, latanoprost
  • Active Comparator: 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
    Interventions:
    • Drug: ibuprofen, latanoprost, brimonidine
    • Drug: Ibuprofen, brimonidine, latanoprost
  • Active Comparator: 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
    Interventions:
    • Drug: ibuprofen, latanoprost, brimonidine
    • Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2011)
51
Original Enrollment  ICMJE
 (submitted: November 21, 2006)
50
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00402493
Other Study ID Numbers  ICMJE GA6110HV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philadelphia Eye Associates
Study Sponsor  ICMJE Philadelphia Eye Associates
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Joseph I. Markoff, Ph.D,M.DPhiladelphia Eye Associates
PRS Account Philadelphia Eye Associates
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP