Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
175 participants
OBSERVATIONAL
2010-12-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Latanoprost-treatment group
No intervention other than routine medical care
Subjects continuously treated with Latanoprost for at least one month Latanoprost treatment during the study period.
Non-topical prostaglandin analogue treatment group
No intervention other than routine medical care
Subjects not treated with any topical prostaglandin analogues or continuously treated with topical prostaglandin analogues for less than one month before the baseline examination, and unlikely to be treated with topical prostaglandin analogues during the study period.
Interventions
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No intervention other than routine medical care
Subjects continuously treated with Latanoprost for at least one month Latanoprost treatment during the study period.
No intervention other than routine medical care
Subjects not treated with any topical prostaglandin analogues or continuously treated with topical prostaglandin analogues for less than one month before the baseline examination, and unlikely to be treated with topical prostaglandin analogues during the study period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of pediatric glaucoma or elevated intraocular pressure.
* Evidence of a personally signed and dated informed consent document indicating that the subject (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws.
For treated subjects only:
* Continuously treated with latanoprost for at least 1 month within the year prior to the baseline examination.
For untreated subjects only:
* Continuously treated with latanoprost or other topical prostaglandin analogues for less than one month prior to the baseline examination (based on the best knowledge of treating ophthalmologists), and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period; OR
* No prior treatment with latanoprost or other topical prostaglandin analogues, and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period.
Exclusion Criteria
* Pregnant or nursing females at baseline.
* For treated subjects only: a history of allergy or hypersensitivity to any of the ingredients contained in latanoprost (e.g., hypersensitivity to benzalkonium chloride).
1 Day
17 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie
Edegem, , Belgium
Universitair Ziekenhuis Leuven - Campus Sint-Raphaël
Leuven, , Belgium
Clinica de Oftalmologia San Diego
Medellín, Antioquia, Colombia
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Rigshospitalet - Glostrup
Glostrup Municipality, , Denmark
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Cedex 19, France
CHU d'Amiens -Centre Saint Victor
Amiens, , France
Hopital Claude Huriez
Lille, , France
Universitaetsklinikum Giessen und Marburg
Giessen, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsklinikum Mainz
Mainz, , Germany
University General Hospital of Thessaloniki AHEPA
Thessaloniki, , Greece
Azienda Ospedaliero Univ.
Catania, CT, Italy
Ospedale Pediatrico Bambino Gesu
Fiumicino (Roma), , Italy
Istituto Giannina Gaslini, Divisione di Oculistica
Genova, , Italy
Unita' Operativa di Oculistica Pediatrica, Azienda Ospedaliera Ospedale Niguarda Ca'Grande
Milan, , Italy
Óptima Visión
Miraflores, Lima region, Peru
AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem
Coimbra, , Portugal
Detska Fakultna nemocnica s poliklinikou Bratislava
Bratislava, , Slovakia
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Virgen Del Rocio
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Akademiska Sjukhuset
Uppsala, , Sweden
Ögonkliniken, Centrallasarettet
Västerås, , Sweden
Manchester Royal Eye Hospital
Manchester, GT MAN, United Kingdom
Birmingham and Midland Eye Centre, Consultant Ophthalmologist
Birmingham, , United Kingdom
Richard Desmond Childrens Eye Centre
London, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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PFI-LAT-2009-01
Identifier Type: OTHER
Identifier Source: secondary_id
LYNX
Identifier Type: OTHER
Identifier Source: secondary_id
A6111143
Identifier Type: -
Identifier Source: org_study_id
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