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Long-Term Non-Interventional Latanoprost Study (LYNX)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01265719
First received: December 16, 2010
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Other: No intervention other than routine medical care
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Refractive error [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Refractive error [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Refractive error [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Refractive error [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Refractive error [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Iris color darkening [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Iris color darkening [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Iris color darkening [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Iris color darkening [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Iris color darkening [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Eyelash darkening/thickening [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Eyelash darkening/thickening [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Eyelash darkening/thickening [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Eyelash darkening/thickening [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Eyelash darkening/thickening [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Corneal thickness [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Corneal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Corneal thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Corneal thickness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Corneal thickness [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Conjunctiva hyperemia [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Conjunctiva hyperemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Conjunctiva hyperemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Conjunctiva hyperemia [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Conjunctiva hyperemia [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: December 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Latanoprost-treatment group Other: No intervention other than routine medical care
Subjects continuously treated with Latanoprost for at least one month Latanoprost treatment during the study period.
Other Name: Observational
Non-topical prostaglandin analogue treatment group Other: 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 Name: Observational

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

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric populations diagnosed with glaucoma or elevated intraocular pressure

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265719

  Hide Study Locations
Locations
Belgium
Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie
Edegem, Belgium, 2650
Universitair Ziekenhuis Leuven - Campus Sint-Raphaël
Leuven, Belgium, 3000
Colombia
Clinica de Oftalmologia San Diego
Medellin, Antioquia, Colombia
Czech Republic
Fakultni nemocnice Brno
Brno, Czech Republic, 613 00
Fakultni nemocnice v Motole
Praha 5, Czech Republic, 150 06
Denmark
Glostrup Hospital
Glostrup, Denmark, 2600
France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Cedex 19, France, 75940
CHU d'Amiens -Centre Saint Victor
Amiens, France, 80000
Hopital Claude Huriez
Lille Cedex, France, 59037
Germany
Universitaetsklinikum Giessen und Marburg
Giessen, Hessen, Germany, 35392
Universitaetsklinikum Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Greece
University General Hospital of Thessaloniki AHEPA
Thessaloniki, Greece, 54636
Italy
Azienda Ospedaliero Univ.
Catania, CT, Italy, 95123
Ospedale Pediatrico Bambino Gesu
Fiumicino (Roma), Italy, 00050
Istituto Giannina Gaslini, Divisione di Oculistica
Genova, Italy, 16147
Unita' Operativa di Oculistica Pediatrica, Azienda Ospedaliera Ospedale Niguarda Ca'Grande
Milano, Italy, 20162
Peru
Óptima Visión
Miraflores, Lima, Peru, L 18
Portugal
AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem
Coimbra, Portugal, 3000-354
Slovakia
Detska Fakultna nemocnica s poliklinikou Bratislava
Bratislava, Slovakia, 83340
Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Virgen Del Rocio
Sevilla, Spain, 41013
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sweden
Akademiska Sjukhuset
Uppsala, Sweden, 751 85
Ögonkliniken, Centrallasarettet
Västerås, Sweden, 721 89
United Kingdom
Manchester Royal Eye Hospital
Manchester, Gt Man, United Kingdom, M13 9WH
Birmingham and Midland Eye Centre, Consultant Ophthalmologist
Birmingham, United Kingdom, B18 7QH
Richard Desmond Childrens Eye Centre
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01265719     History of Changes
Other Study ID Numbers: A6111143, LYNX
Study First Received: December 16, 2010
Last Updated: October 27, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
Prospective
non-interventional
longitudinal
cohort study

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014