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

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

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

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.