A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

NCT ID: NCT00716859

Last Updated: 2021-02-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-11-30

Brief Summary

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To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Timolol

Group Type ACTIVE_COMPARATOR

Timolol

Intervention Type DRUG

Timolol 0.5% dosed twice-daily

latanoprost

Group Type EXPERIMENTAL

latanoprost

Intervention Type DRUG

Latanoprost 0.005% ophthalmic solution dosed once-daily

Interventions

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Timolol

Timolol 0.5% dosed twice-daily

Intervention Type DRUG

latanoprost

Latanoprost 0.005% ophthalmic solution dosed once-daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female of 18 years of age or under
* Diagnosis of glaucoma
* IOP of 22 mmHg or above in at least 1 eye

Exclusion Criteria

* Require surgery for acute angle closure
* Have had prior cyclodestructive procedures
* Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit
Minimum Eligible Age

36 Weeks

Maximum Eligible Age

18 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

Pembroke Pines, Florida, United States

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Atlanta, Georgia, United States

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Indianapolis, Indiana, United States

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Minneapolis, Minnesota, United States

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Henderson, Nevada, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Leuven, , Belgium

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MedellĂ­n, Antioquia, Colombia

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Bogota, Cundinamarca, Colombia

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Prague, , Czechia

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Amiens, Cedex 1, France

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Lille, , France

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Lyon, , France

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Regenstauf, , Germany

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Schorndorf, , Germany

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Hyderabad, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Coimbatore, Tamil Nadu, India

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Catania, , Italy

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Milan, , Italy

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Makati City, , Philippines

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Mandaluyong, , Philippines

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Bialystok, , Poland

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Gdansk, , Poland

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Wroclaw, , Poland

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Cluj-Napoca, Cluj, Romania

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Moscow, , Russia

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Saint Petersburg, , Russia

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Belgrade, , Serbia

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Bratislava, , Slovakia

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Ljubljana, , Slovenia

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Myfair West, , South Africa

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Esplugues de Llobregat, Barcelona, Spain

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Madrid, , Spain

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Seville, , Spain

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Birmingham, , United Kingdom

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London, , United Kingdom

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Countries

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United States Belgium Colombia Czechia France Germany India Italy Philippines Poland Portugal Romania Russia Serbia Slovakia Slovenia South Africa Spain Ukraine United Kingdom

Related Links

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Other Identifiers

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A6111137

Identifier Type: -

Identifier Source: org_study_id

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