Long-Term Non-Interventional Latanoprost Study

Glaucoma Clinical Trial

— LYNX  

Official title:

A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265719
• Other study ID #: A6111143
• Secondary ID: PFI-LAT-2009-01L
• Status: Completed
• Start date: December 2010
• Est. completion date: February 2016

Study information

• Verified date: February 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie	Edegem
Belgium	Universitair Ziekenhuis Leuven - Campus Sint-Raphaël	Leuven
Colombia	Clinica de Oftalmologia San Diego	Medellin	Antioquia
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice v Motole	Praha 5
Denmark	Rigshospitalet - Glostrup	Glostrup
France	CHU d'Amiens -Centre Saint Victor	Amiens
France	Hopital Claude Huriez	Lille Cedex
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris	Cedex 19
Germany	Universitaetsklinikum Giessen und Marburg	Giessen
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitaetsklinikum Mainz	Mainz
Greece	University General Hospital of Thessaloniki AHEPA	Thessaloniki
Italy	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	Milano
Peru	Óptima Visión	Miraflores	Lima
Portugal	AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem	Coimbra
Slovakia	Detska Fakultna nemocnica s poliklinikou Bratislava	Bratislava
Spain	Hospital Sant Joan de Deu	Esplugues de Llobregat	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Virgen Del Rocio	Sevilla
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Akademiska Sjukhuset	Uppsala
Sweden	Ögonkliniken, Centrallasarettet	Västerås
United Kingdom	Birmingham and Midland Eye Centre, Consultant Ophthalmologist	Birmingham
United Kingdom	Richard Desmond Childrens Eye Centre	London
United Kingdom	Manchester Royal Eye Hospital	Manchester	Gt Man

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Belgium,  Colombia,  Czechia,  Denmark,  France,  Germany,  Greece,  Italy,  Peru,  Portugal,  Slovakia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Clinically Meaningful Change in Refractive Error	The refractive error [cycloplegic where appropriate (eg, those unable to cooperate with manifest refraction)] were determined at the baseline visit and assessed at the following visits.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler)	The horizontal corneal diameter was measured along the horizontal meridians. Diameter was measured using either a series of transparent plates with holes of different diameters in quarter-millimeter increments or with calibrated calipers compared against a ruler. When using calipers, the corneal diameter measurement was taken from limbus to a similar point 180° away at the opposite limbus. When not examining the children with anesthesia, it was recommended to use a tape measure across the head while measuring horizontal corneal diameter by photographic method.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)	IOP was preferably measured using 1 of 3 applanation-contact methods: Goldmann applanation tonometry, Perkins tonometry, or TonoPen® (tonometry). iCare® rebound tonometer was also allowed if it was used consistently throughout the study.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios	The cup/disc ratio was recorded horizontally and vertically for each examination, and reported in 0.1 increments.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects.	A visual field examination was performed for those patients who can cooperate automated perimetry utilizing a threshold program. All visual fields was conducted utilizing the standard white background with a Goldmann size III white stimulus. For those patients who can not perform formal visual field testing, then field to confrontation test was used for younger, non-verbal children, central, steady and maintains fixation was used.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Iris Color Darkening	Changes from baseline in iris color were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid	Changes from baseline in localized pigmentation (nevi and freckles) of the conjunctiva, iris and choroid were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Eyelash Darkening/Thickening	Changes from baseline in eyelash darkening/thickening/lengthening were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler)	The longest eyelash (mm) measured by caliper or ruler was recorded at baseline and each follow-up visit.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter)	Central corneal thickness was measured using a calibrated pachymeter, preferably an ultrasonic pachymeter.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Conjunctival/Ocular Hyperemia	Conjunctiva hyperemia was assessed by slit-lamp examination. When slit-lamp examination is not possible due to subject cooperation, a fixation light and 20-diopter lens (for magnification) was used to assess this parameter. Conjunctival hyperemia was assessed and graded by ophthalmologist at baseline and follow-up visits from grades 0-3 and is as follows: 0 = None, Normal: few vessels of palpebral or bulbar conjunctiva easily observed; = Mild, Reddening of the palpebral or bulbar conjunctiva; = Moderate, Bright reddening of the palpebral or bulbar conjunctiva; = Severe, Deep, bright, and diffuse reddening of the palpebral or bulbar conjunctiva	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Number of Participants With a Change in Anterior Segment Biomicroscopy	Slit-lamp biomicroscopy (mounted or hand-held) without fluorescein and without dilation of the pupil was performed. When slit-lamp examination was not possible, a fixation light and 20-diopter lens (for magnification) was used. At each scheduled visit, deposition of pigment on the corneal endothelial layer or the lens capsule or any abnormalities of the lids, conjunctivae, cornea, anterior chamber, iris, or lens was examined.	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Secondary	Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline	Fundoscopy was performed after dilation of the pupils (eg, 1 % tropicamide or cyclopentolate and 2 ½ % phenylephrine, or a clinically- appropriate dose according to the clinician's standard care of each particular patient). The examination included an evaluation of the vitreous body, retina (including the macula), and optic nerve head.; The fundoscopy e-CRF was completed only at baseline because the investigators were required to perform slit lamp, direct or indirect ophthalmoscopy at each visit and report any AEs observed which included the vitreous, retina and optic nerve.	Evaluated at Baseline

External Links

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