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

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 Scandinavia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751062
• Other study ID #: 9200PG006
• Secondary ID: A6111130
• Status: Completed
• Phase: Phase 3
• Start date: November 1992
• Est. completion date: December 1993

Study information

• Verified date: September 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• 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.

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

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
Denmark	Pfizer Investigational Site	Hellerup
Denmark	Pfizer Investigational Site	Vejle
Finland	Pfizer Investigational Site	Oulu
Norway	Pfizer Investigational Site	Bergen
Norway	Pfizer Investigational Site	Oslo
Norway	Pfizer Investigational Site	Trondheim
Sweden	Pfizer Investigational Site	Gothenburg
Sweden	Pfizer Investigational Site	Huddinge
Sweden	Pfizer Investigational Site	Linkoping
Sweden	Pfizer Investigational Site	Lund
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Umea
Sweden	Pfizer Investigational Site	Uppsala

Sponsors (1)

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

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

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 demonstrate the IOP-reducing effect of PhXA41 administered in the morning is equivalent the effect of PhXA41 administered in the evening		6 mos

External Links

•   To obtain contact information for a study center near you, click here.