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

NCT ID: NCT00751049

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-12-31

Study Completion Date

1993-12-31

Brief Summary

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

Detailed Description

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Conditions

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Ocular Hypertension Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PhXA41

Group Type EXPERIMENTAL

PhXA41

Intervention Type DRUG

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

timolol

Group Type ACTIVE_COMPARATOR

timolol

Intervention Type DRUG

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

Interventions

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timolol

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

Intervention Type DRUG

PhXA41

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

Intervention Type DRUG

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:

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Aberdeen, Grampian, United Kingdom

Site Status

Pfizer Investigational Site

Nottingham, Notts., United Kingdom

Site Status

Pfizer Investigational Site

Bristol, , United Kingdom

Site Status

Pfizer Investigational Site

Cambridge, , United Kingdom

Site Status

Pfizer Investigational Site

Cardiff, , United Kingdom

Site Status

Pfizer Investigational Site

Dundee, , United Kingdom

Site Status

Pfizer Investigational Site

Liverpool, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

Manchester, , United Kingdom

Site Status

Pfizer Investigational Site

Paisley, , United Kingdom

Site Status

Pfizer Investigational Site

Sheffield, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 19427617 (View on PubMed)

Related Links

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Other Identifiers

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A6111129

Identifier Type: -

Identifier Source: secondary_id

9200PG005

Identifier Type: -

Identifier Source: org_study_id

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