Status:
COMPLETED
A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Ocular Hypertension
Open Angle Glaucoma
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure
Eligibility Criteria
Inclusion
- 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:
- 3 weeks for B-adrenergic antagonists
- 2 weeks for adrenergic agonists
- 5 days for cholinergics and oral carbonic anhydrase inhibitors.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1993
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT00751049
Start Date
December 1 1992
End Date
December 1 1993
Last Update
February 2 2021
Active Locations (12)
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1
Pfizer Investigational Site
Aberdeen, Grampian, United Kingdom, AB25 2ZD
2
Pfizer Investigational Site
Nottingham, Notts., United Kingdom, NG7 2UH
3
Pfizer Investigational Site
Bristol, United Kingdom, BS1 2LX
4
Pfizer Investigational Site
Cambridge, United Kingdom