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A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension

Last updated on November 19, 2019

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Study Location
Pfizer Investigational Site
La Jolla, California, 92093-0946 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma, Open Angle Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary
glaucoma or ocular hypertension.

- Open angle glaucoma appearing more than 6 months after cataract surgery is recognized
as primary open angle glaucoma. (individuals requiring treatment bilaterally must
fulfill eligibility criteria for both eyes.)

- IOP of 22mmHg or higher obtained during the pre-study period.

- Patients currently not treated or on single-drug treatment for the elevated IOP are
eligible after a medication free period (wash-out) of:

1. 3 weeks for B-adrenergic antagonists

2. 2 weeks for adrenergic agonists

3. 5 days for cholinergics and oral carbonic anhydrase inhibitors.

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

- History of acute angle closure.

- Severe trauma at any time.

- Intraocular surgery or argon laser trabeculoplasty within 6 months.

- Current use of contact lenses.

- History of severe dry eye syndrome.

- Ocular inflammation/infection with three months of inclusion.

- Any condition preventing reliable applanation tonometry.

- Unacceptable finding at pre-study ocular examination as specified in the Case Report
Forms.

- In Investigator regards monotherapy insufficient with respect to optic nerve head
and/or visual field status.

- Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a
period longer than 3 months and/or treatment at any time during 6 months prior to
study start.

- Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular
block.

- Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary
disease.

- Having participated in any other clinical study within the last month.

NCT00751127
Pfizer
Completed
A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension

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Descriptive Information
Brief Title  ICMJE A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE A 6-month, Randomized, Double-masked Comparison of Latanoprost (PhXA41) With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-centre Study in the United States.
Brief SummaryPhXA41 is not inferior to timolol
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Open Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: PhXA41
    One drop in the affected eye once daily for six months.
  • Drug: timolol
    One drop in the affected eye twice daily for six months.
Study Arms  ICMJE
  • Active Comparator: Timolol
    Intervention: Drug: timolol
  • Experimental: PhXA41
    Intervention: Drug: PhXA41
Publications *Varma R, Hwang LJ, Grunden JW, Bean GW, Sultan MB. Assessing the efficacy of latanoprost vs timolol using an alternate efficacy parameter: the intervisit intraocular pressure range. Am J Ophthalmol. 2009 Aug;148(2):221-6. doi: 10.1016/j.ajo.2009.02.035. Epub 2009 May 9.


*   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: September 10, 2008)
268
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1994
Actual Primary Completion DateFebruary 1994   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
  • Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
  • IOP of 22mmHg or higher obtained during the pre-study period.
  • Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:

    1. 3 weeks for B-adrenergic antagonists
    2. 2 weeks for adrenergic agonists
    3. 5 days for cholinergics and oral carbonic anhydrase inhibitors.

Exclusion Criteria:

  • History of acute angle closure.
  • Severe trauma at any time.
  • Intraocular surgery or argon laser trabeculoplasty within 6 months.
  • Current use of contact lenses.
  • History of severe dry eye syndrome.
  • Ocular inflammation/infection with three months of inclusion.
  • Any condition preventing reliable applanation tonometry.
  • Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
  • In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
  • Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
  • Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
  • Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
  • Having participated in any other clinical study within the last month.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 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 NCT00751127
Other Study ID Numbers  ICMJE 9200PG004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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