Ocular Hypertension, Open Angle Glaucoma
Conditions
Keywords
open angle glaucoma ocular hypertension
Brief summary
Study PhXA41 for its non-inferiority compared with timolol in lowering 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.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
No
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.
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 describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups. | 6 mos |
Countries
United Kingdom
Outcome results
None listed