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NCT00751049 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00751049
Other study ID # 9200PG005
Secondary ID A6111129
Status Completed
Phase Phase 3
First received
Last updated
Start date December 1992
Est. completion date December 1993

Study information
Verified date September 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 294
Est. completion date December 1993
Est. primary completion date December 1993
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• timolol
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
• PhXA41
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.

Locations
Country Name City State
United Kingdom Pfizer Investigational Site Aberdeen Grampian
United Kingdom Pfizer Investigational Site Bristol
United Kingdom Pfizer Investigational Site Cambridge
United Kingdom Pfizer Investigational Site Cardiff
United Kingdom Pfizer Investigational Site Dundee
United Kingdom Pfizer Investigational Site Liverpool
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Nottingham Notts.
United Kingdom Pfizer Investigational Site Paisley
United Kingdom Pfizer Investigational Site Sheffield

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups. 6 mos
See also
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Completed NCT01410188 - Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension Phase 1/Phase 2
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