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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00751049

Collaborator

(none)

294

Enrollment

Locations

Arms

Duration (Months)

24.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Open Angle Glaucoma	Drug: timolol Drug: PhXA41	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

294 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Dec 1, 1992

Actual Primary Completion Date :

Dec 1, 1993

Actual Study Completion Date :

Dec 1, 1993

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [6 mos]

Secondary Outcome Measures

to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups. [6 mos]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

3 weeks for B-adrenergic antagonists
2 weeks for adrenergic agonists
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

Locations

	Site	City	State	Country	Postal Code
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
5	Pfizer Investigational Site	Cardiff		United Kingdom	CF4 4XW
6	Pfizer Investigational Site	Dundee		United Kingdom	DD2 9SY
7	Pfizer Investigational Site	Liverpool		United Kingdom	L7 8XP
8	Pfizer Investigational Site	London		United Kingdom	NW3 2QG
9	Pfizer Investigational Site	London		United Kingdom
10	Pfizer Investigational Site	Manchester		United Kingdom
11	Pfizer Investigational Site	Paisley		United Kingdom
12	Pfizer Investigational Site	Sheffield		United Kingdom	S10 2JF