A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00751062
First received: September 10, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

PhXA41 is not inferior to timolol in reducing intra-ocular pressure


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
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 Scandinavia

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 demonstrate the IOP-reducing effect of PhXA41 administered in the morning is equivalent the effect of PhXA41 administered in the evening [ Time Frame: 6 mos ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: November 1992
Study Completion Date: December 1993
Primary Completion Date: December 1993 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  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.

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: NCT00751062

Locations
Denmark
Pfizer Investigational Site
Hellerup, Denmark
Pfizer Investigational Site
Vejle, Denmark
Finland
Pfizer Investigational Site
Oulu, Finland
Norway
Pfizer Investigational Site
Bergen, Norway
Pfizer Investigational Site
Oslo, Norway
Pfizer Investigational Site
Trondheim, Norway
Sweden
Pfizer Investigational Site
Gothenburg, Sweden
Pfizer Investigational Site
Huddinge, Sweden, 141 86
Pfizer Investigational Site
Linkoping, Sweden, 581 85
Pfizer Investigational Site
Lund, Sweden
Pfizer Investigational Site
Malmo, Sweden, 205 02
Pfizer Investigational Site
Umea, Sweden
Pfizer Investigational Site
Uppsala, Sweden
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: NCT00751062     History of Changes
Other Study ID Numbers: 9200PG006, A6111130
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:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
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 July 29, 2014