Trial record 19 of 958 for:    "Glaucoma"

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00751127
First received: September 10, 2008
Last updated: March 24, 2011
Last verified: September 2008
  Purpose

PhXA41 is not inferior to timolol


Condition Intervention Phase
Glaucoma
Open Angle Glaucoma
Ocular Hypertension
Drug: PhXA41
Drug: timolol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups. [ Time Frame: 6 mos ] [ Designated as safety issue: No ]

Enrollment: 268
Study Start Date: January 1993
Study Completion Date: February 1994
Primary Completion Date: February 1994 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Timolol Drug: timolol
One drop in the affected eye twice daily for six months.
Experimental: PhXA41 Drug: PhXA41
One drop in the affected eye once daily for six months.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751127

Locations
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92093-0946
Pfizer Investigational Site
Los Angeles, California, United States, 90033
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40292
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21209
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68105
United States, New Jersey
Pfizer Investigational Site
River Edge, New Jersey, United States, 07661-1931
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
New York, New York, United States, 10003
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210-3049
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107-5599
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425-0001
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53705-3611
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00751127     History of Changes
Other Study ID Numbers: 9200PG004
Study First Received: September 10, 2008
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
open angle glaucoma
ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Timolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on October 01, 2014