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

Viatris

Status and phase

Completed

Phase 3

Conditions

Open Angle Glaucoma

Ocular Hypertension

Treatments

Drug: timolol

Drug: PhXA41

Study type

Interventional

Funder types

Industry

Identifiers

A6111129

9200PG005

Details and patient eligibility

About

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

Enrollment

294 patients

Sex

All

Ages

40+ years old

Volunteers

No 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:
1. 3 weeks for B-adrenergic antagonists
2. 2 weeks for adrenergic agonists
3. 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.