A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension
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.
1 other identifier
interventional
268
1 country
17
Brief Summary
PhXA41 is not inferior to timolol
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 1993
Shorter than P25 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1993
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 1994
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 1994
CompletedFirst Submitted
Initial submission to the registry
September 10, 2008
CompletedFirst Posted
Study publicly available on registry
September 11, 2008
CompletedMarch 25, 2011
September 1, 2008
1.1 years
September 10, 2008
March 24, 2011
Conditions
Keywords
Outcome Measures
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.
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.
6 mos
Study Arms (2)
Timolol
ACTIVE COMPARATORPhXA41
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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:
- weeks for B-adrenergic antagonists
- weeks for adrenergic agonists
- days for cholinergics and oral carbonic anhydrase inhibitors.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (17)
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
Related Publications (1)
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.
PMID: 19427617DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2008
First Posted
September 11, 2008
Study Start
January 1, 1993
Primary Completion
February 1, 1994
Study Completion
February 1, 1994
Last Updated
March 25, 2011
Record last verified: 2008-09