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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00751062

Collaborator

(none)

267

Enrollment

Locations

Arms

Duration (Months)

20.5

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

267 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 Scandinavia

Study Start Date :

Nov 1, 1992

Actual Primary Completion Date :

Dec 1, 1993

Actual Study Completion Date :

Dec 1, 1993

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

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 demonstrate the IOP-reducing effect of PhXA41 administered in the morning is equivalent the effect of PhXA41 administered in the evening [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.

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	Country	Postal Code
1	Pfizer Investigational Site	Hellerup	Denmark
2	Pfizer Investigational Site	Vejle	Denmark
3	Pfizer Investigational Site	Oulu	Finland
4	Pfizer Investigational Site	Bergen	Norway
5	Pfizer Investigational Site	Oslo	Norway
6	Pfizer Investigational Site	Trondheim	Norway
7	Pfizer Investigational Site	Gothenburg	Sweden
8	Pfizer Investigational Site	Huddinge	Sweden	141 86
9	Pfizer Investigational Site	Linkoping	Sweden	581 85
10	Pfizer Investigational Site	Lund	Sweden
11	Pfizer Investigational Site	Malmo	Sweden	205 02
12	Pfizer Investigational Site	Umea	Sweden
13	Pfizer Investigational Site	Uppsala	Sweden