Clinical trial NCT01265719: Long-Term Non-Interventional Latanoprost Study
Official title: A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Ocular Hypertension
Keywords: Prospective
non-interventional
longitudinal
cohort study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-23
Enrollment: 175
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric populations diagnosed with glaucoma or elevated intraocular pressure

Brief summary: This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team.

Detailed description: At least 40 subjects in each of the following age groups: 1-\<5 years and 5-\<18 years. No minimum required numbers in the \<1 year age group.

Eligibility criteria: Inclusion Criteria:

* Male or female \<18 years of age (neonates must be at least 36 weeks gestational age).
* 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:

* Unable/unwilling to comply with protocol.
* 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).

Primary outcomes:
measure: Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary outcomes:
measure: Number of Participants With Clinically Meaningful Change in Refractive Error
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler)
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects.
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Iris Color Darkening
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Eyelash Darkening/Thickening
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler)
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter)
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Conjunctival/Ocular Hyperemia
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Number of Participants With a Change in Anterior Segment Biomicroscopy
timeFrame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
measure: Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline
timeFrame: Evaluated at Baseline
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Sint-Raphaël
city: Medellin
country: Colombia
facility: Clinica de Oftalmologia San Diego
state: Antioquia
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Glostrup
country: Denmark
facility: Rigshospitalet - Glostrup
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
state: Cedex 19
city: Amiens
country: France
facility: CHU d'Amiens -Centre Saint Victor
city: Lille Cedex
country: France
facility: Hopital Claude Huriez
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Mainz
country: Germany
facility: Universitaetsklinikum Mainz
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki AHEPA
city: Catania
country: Italy
facility: Azienda Ospedaliero Univ.
state: CT
city: Fiumicino (Roma)
country: Italy
facility: Ospedale Pediatrico Bambino Gesu
city: Genova
country: Italy
facility: Istituto Giannina Gaslini, Divisione di Oculistica
city: Milano
country: Italy
facility: Unita' Operativa di Oculistica Pediatrica, Azienda Ospedaliera Ospedale Niguarda Ca'Grande
city: Miraflores
country: Peru
facility: Óptima Visión
state: Lima
city: Coimbra
country: Portugal
facility: AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem
city: Bratislava
country: Slovakia
facility: Detska Fakultna nemocnica s poliklinikou Bratislava
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Västerås
country: Sweden
facility: Ögonkliniken, Centrallasarettet
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
state: Gt Man
city: Birmingham
country: United Kingdom
facility: Birmingham and Midland Eye Centre, Consultant Ophthalmologist
city: London
country: United Kingdom
facility: Richard Desmond Childrens Eye Centre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: