Long-Term Non-Interventional Latanoprost Study

NCT01265719 | Completed Results

• 3 other identifiers: A6111143PFI-LAT-2009-01LYNX
• Study Type: observational
• Target: 175
• Locations: 14 countries
• Sites: 29

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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

Prospective; non-interventional; longitudinal; cohort study

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)

  Patients familiar with the letters of the alphabet were evaluated using Snellen visual acuity. Patients who were unable or unfamiliar with the letters of the alphabet were evaluated using charts made up of numbers, pictures (eg, Schering's Children's Eye Chart or Allen Cards), E's, or Landolt's broken rings, and other methods which were equivalent to Snellen acuity eg, HOTV testing).

  Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months

Secondary Outcomes (13)

• Number of Participants With Clinically Meaningful Change in Refractive Error

  Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months

• Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler)

  Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months

• Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)

  Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months

• Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios

  Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months

• Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects.

  Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months

Study Arms (2)

Latanoprost-treatment group

Other: No intervention other than routine medical care

Non-topical prostaglandin analogue treatment group

Other: No intervention other than routine medical care

Interventions

No intervention other than routine medical care OTHER

Subjects continuously treated with Latanoprost for at least one month Latanoprost treatment during the study period.

Also known as: Observational

Latanoprost-treatment group

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric populations diagnosed with glaucoma or elevated intraocular pressure

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (29)

Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Leuven - Campus Sint-Raphaël

Leuven, 3000, Belgium

Location

Clinica de Oftalmologia San Diego

Medellín, Antioquia, 050016, Colombia

Location

Fakultni nemocnice Brno

Brno, 613 00, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Rigshospitalet - Glostrup

Glostrup Municipality, 2600, Denmark

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Cedex 19, 75940, France

Location

CHU d'Amiens -Centre Saint Victor

Amiens, 80000, France

Location

Hopital Claude Huriez

Lille, 59037, France

Location

Universitaetsklinikum Giessen und Marburg

Giessen, 35392, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitaetsklinikum Mainz

Mainz, 55131, Germany

Location

University General Hospital of Thessaloniki AHEPA

Thessaloniki, 54636, Greece

Location

Azienda Ospedaliero Univ.

Catania, CT, 95123, Italy

Location

Ospedale Pediatrico Bambino Gesu

Fiumicino (Roma), 00050, Italy

Location

Istituto Giannina Gaslini, Divisione di Oculistica

Genova, 16147, Italy

Location

Unita' Operativa di Oculistica Pediatrica, Azienda Ospedaliera Ospedale Niguarda Ca'Grande

Milan, 20162, Italy

Location

Óptima Visión

Miraflores, Lima region, L 18, Peru

Location

AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem

Coimbra, 3000-548, Portugal

Location

Detska Fakultna nemocnica s poliklinikou Bratislava

Bratislava, 83340, Slovakia

Location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Akademiska Sjukhuset

Uppsala, 751 85, Sweden

Location

Ögonkliniken, Centrallasarettet

Västerås, 721 89, Sweden

Location

Manchester Royal Eye Hospital

Manchester, GT MAN, M13 9WH, United Kingdom

Location

Birmingham and Midland Eye Centre, Consultant Ophthalmologist

Birmingham, B18 7QH, United Kingdom

Location

Richard Desmond Childrens Eye Centre

London, EC1V 2PD, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Limitations and Caveats

Inherent limitations of an observational study design (eg, lack of randomization), this was subject to the design/data-related limitations mainly Visual acuity, IOP, and visual field assessments in \<5 years old age group were less reliable

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer, Inc

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 3, 2021
• Results First Posted: November 5, 2018

Record last verified: 2018-02

Locations

CO (1); GR (1); BE (2); CZ (2); DK (1); ES (4); PE (1); GB (3); DE (3); PT (1); SL (1); IT (4); SE (2); FR (3)