A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ocular Hypertension; Open Angle Glaucoma
Intervention: timolol (Drug); PhXA41 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment
Secondary outcome: to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Bristol BS1 2LX, United Kingdom
Pfizer Investigational Site, Cambridge, United Kingdom
Pfizer Investigational Site, Cardiff CF4 4XW, United Kingdom
Pfizer Investigational Site, Dundee DD2 9SY, United Kingdom
Pfizer Investigational Site, Liverpool L7 8XP, United Kingdom
Pfizer Investigational Site, London NW3 2QG, United Kingdom
Pfizer Investigational Site, London, United Kingdom
Pfizer Investigational Site, Manchester, United Kingdom
Pfizer Investigational Site, Paisley, United Kingdom
Pfizer Investigational Site, Sheffield S10 2JF, United Kingdom
Pfizer Investigational Site, Aberdeen, Grampian AB25 2ZD, United Kingdom
Pfizer Investigational Site, Nottingham, Notts. NG7 2UH, United Kingdom
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 1992
Last updated: September 10, 2008
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