A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00751049
First received: September 10, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 6-Month, Randomized, Double-Masked Comparison of PhXA41 With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-Centre Study in the United Kingdom

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: 294
Study Start Date: December 1992
Study Completion Date: December 1993
Primary Completion Date: December 1993 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PhXA41 Drug: PhXA41
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
Active Comparator: timolol Drug: timolol
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle

  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: NCT00751049

Locations
United Kingdom
Pfizer Investigational Site
Aberdeen, Grampian, United Kingdom, AB25 2ZD
Pfizer Investigational Site
Nottingham, Notts., United Kingdom, NG7 2UH
Pfizer Investigational Site
Bristol, United Kingdom, BS1 2LX
Pfizer Investigational Site
Cambridge, United Kingdom
Pfizer Investigational Site
Cardiff, United Kingdom, CF4 4XW
Pfizer Investigational Site
Dundee, United Kingdom, DD2 9SY
Pfizer Investigational Site
Liverpool, United Kingdom, L7 8XP
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Pfizer Investigational Site
London, United Kingdom
Pfizer Investigational Site
Manchester, United Kingdom
Pfizer Investigational Site
Paisley, United Kingdom
Pfizer Investigational Site
Sheffield, United Kingdom, S10 2JF
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: NCT00751049     History of Changes
Other Study ID Numbers: 9200PG005, A6111129
Study First Received: September 10, 2008
Last Updated: September 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
open angle glaucoma ocular hypertension

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

ClinicalTrials.gov processed this record on September 18, 2014