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

NCT00751049 | Completed Phase 3

• 2 other identifiers: 9200PG005A6111129
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Ocular Hypertension; Open Angle Glaucoma

Keywords

open angle glaucoma ocular hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.

  6 mos

Study Arms (2)

PhXA41

EXPERIMENTAL

Drug: PhXA41

timolol

ACTIVE COMPARATOR

Drug: timolol

Interventions

timolol DRUG

One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle

timolol

PhXA41 DRUG

One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.

PhXA41

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• weeks for B-adrenergic antagonists
• weeks for adrenergic agonists
• days for cholinergics and oral carbonic anhydrase inhibitors.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (12)

Pfizer Investigational Site

Aberdeen, Grampian, AB25 2ZD, United Kingdom

Location

Pfizer Investigational Site

Nottingham, Notts., NG7 2UH, United Kingdom

Location

Pfizer Investigational Site

Bristol, BS1 2LX, United Kingdom

Location

Pfizer Investigational Site

Cambridge, United Kingdom

Location

Pfizer Investigational Site

Cardiff, CF4 4XW, United Kingdom

Location

Pfizer Investigational Site

Dundee, DD2 9SY, United Kingdom

Location

Pfizer Investigational Site

Liverpool, L7 8XP, United Kingdom

Location

Pfizer Investigational Site

London, NW3 2QG, United Kingdom

Location

Pfizer Investigational Site

London, United Kingdom

Location

Pfizer Investigational Site

Manchester, United Kingdom

Location

Pfizer Investigational Site

Paisley, United Kingdom

Location

Pfizer Investigational Site

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (1)

• Varma R, Hwang LJ, Grunden JW, Bean GW, Sultan MB. Assessing the efficacy of latanoprost vs timolol using an alternate efficacy parameter: the intervisit intraocular pressure range. Am J Ophthalmol. 2009 Aug;148(2):221-6. doi: 10.1016/j.ajo.2009.02.035. Epub 2009 May 9.

  PMID: 19427617 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

Timolol; Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: December 1, 1992
• Primary Completion: December 1, 1993
• Study Completion: December 1, 1993
• Last Updated: February 2, 2021

Record last verified: 2008-09

Locations

GB (12)