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

Phase 3

Completed

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: PhXA41; Drug: timolol

• Registration Number: NCT00751049
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1992-12
• Primary Completion: 1993-12
• Study Completion: 1993-12
• Status Verified: 2008-09
• Study First Submitted: 2008-09-10
• Study First Submitted QC: 2008-09-10
• Study First Posted: 2008-09-11
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PhXA41	PhXA41	-
timolol	timolol	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.	6 mos

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Sheffield, United Kingdom