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CompletedNCT00751127Updated Mar 25, 2011

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

A Phase 3 interventional study of PhXA41 and timolol in Glaucoma, Open Angle Glaucoma and Ocular Hypertension, sponsored by Pfizer. Completed at 17 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-03-25.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
268
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

PhXA41 is not inferior to timolol

02

Conditions studied

  • Glaucoma
  • Open Angle Glaucoma
  • Ocular Hypertension

Keywords

  • open angle glaucoma
  • ocular hypertension
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 268 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
268 participants (actual)

Study arms

  • Active comparator
    Timolol

    Drug: timolol

  • Experimental
    PhXA41

    Drug: PhXA41

Interventions

  • DrugPhXA41

    One drop in the affected eye once daily for six months.

  • Drugtimolol

    One drop in the affected eye twice daily for six months.

06

What researchers measure

Primary outcomes

  1. to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment.

    Time frame: 6 mos

Secondary outcomes

  1. to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.

    Time frame: 6 mos

07

Study locations

17 sites
  • Pfizer Investigational Site
    La Jolla, California 92093-0946, United States
  • Pfizer Investigational Site
    Los Angeles, California 90033, United States
  • Pfizer Investigational Site
    Gainesville, Florida 32610, United States
  • Pfizer Investigational Site
    Chicago, Illinois 60611, United States
  • Pfizer Investigational Site
    Chicago, Illinois 60612, United States
  • Pfizer Investigational Site
    Louisville, Kentucky 40292, United States
  • Pfizer Investigational Site
    Baltimore, Maryland 21209, United States
  • Pfizer Investigational Site
    Ann Arbor, Michigan, United States
  • Pfizer Investigational Site
    St. Louis, Missouri 63110, United States
  • Pfizer Investigational Site
    Omaha, Nebraska 68105, United States
  • Pfizer Investigational Site
    River Edge, New Jersey 07661-1931, United States
  • Pfizer Investigational Site
    New York, New York 10003, United States
  • Pfizer Investigational Site
    New York, New York 10029, United States
  • Pfizer Investigational Site
    Portland, Oregon 97210-3049, United States
  • Pfizer Investigational Site
    Philadelphia, Pennsylvania 19107-5599, United States
  • Pfizer Investigational Site
    Charleston, South Carolina 29425-0001, United States
  • Pfizer Investigational Site
    Madison, Wisconsin 53705-3611, United States
08

References and documents

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. PubMed 19427617 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00751127
Lead sponsor
Pfizer
First posted
Sep 11, 2008
Start date
Jan 1993
Primary completion
Feb 1994
Completion
Feb 1994
Last update
Mar 25, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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