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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00751062

Enrollment

267

Registered

2008-09-11

Start date

1992-11-30

Completion date

1993-12-31

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open Angle Glaucoma

Keywords

open angle glaucoma ocular hypertension

Brief summary

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

Interventions

DRUGtimolol

One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.

DRUGPhXA41

One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Denmark, Finland, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026