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

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

Official Title
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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 the United Kingdom

Conditions
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Ocular Hypertension, Open Angle Glaucoma

Intervention / Treatment
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* Drug: timolol
* Drug: PhXA41


Participation Criteria
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Eligibility Criteria
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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: 3 weeks for B-adrenergic antagonists 2 weeks for adrenergic agonists 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PhXA41<br> | Drug: PhXA41<br>* One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.<br>|
| Active Comparator: timolol<br> | Drug: timolol<br>* One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups. |  | 6 mos | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open angle glaucoma ocular hypertension