Long-Term Non-Interventional Latanoprost Study

Completed

Conditions: Ocular Hypertension
Glaucoma

Interventions: Other: No intervention other than routine medical care

Registration Number: NCT01265719

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 175

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).

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Latanoprost-treatment group	No intervention other than routine medical care	-
Non-topical prostaglandin analogue treatment group	No intervention other than routine medical care	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	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).

Secondary Outcome Measures

Name	Time	Method
Iris Color Darkening	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	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.
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	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.
Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	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.
Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler)	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	The longest eyelash (mm) measured by caliper or ruler was recorded at baseline and each follow-up visit.
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	The cup/disc ratio was recorded horizontally and vertically for each examination, and reported in 0.1 increments.
Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	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.
Eyelash Darkening/Thickening	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	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.
Number of Participants With Clinically Meaningful Change in Refractive Error	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	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.
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	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.
Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter)	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	Central corneal thickness was measured using a calibrated pachymeter, preferably an ultrasonic pachymeter.
Conjunctival/Ocular Hyperemia	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	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 1. = Mild, Reddening of the palpebral or bulbar conjunctiva 2. = Moderate, Bright reddening of the palpebral or bulbar conjunctiva 3. = Severe, Deep, bright, and diffuse reddening of the palpebral or bulbar conjunctiva
Number of Participants With a Change in Anterior Segment Biomicroscopy	Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months	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.
Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline	Evaluated 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.

Trial Locations

Locations (29): University General Hospital of Thessaloniki AHEPA
🇬🇷
Thessaloniki, Greece
CHU d'Amiens -Centre Saint Victor
🇫🇷
Amiens, France
Fakultni nemocnice v Motole
🇨🇿
Praha 5, Czechia
Hospital Virgen Del Rocio
🇪🇸
Sevilla, Spain
Detska Fakultna nemocnica s poliklinikou Bratislava
🇸🇰
Bratislava, Slovakia
Akademiska Sjukhuset
🇸🇪
Uppsala, Sweden
Hopital Claude Huriez
🇫🇷
Lille Cedex, France
Hospital Universitario Miguel Servet
🇪🇸
Zaragoza, Spain
Richard Desmond Childrens Eye Centre
🇬🇧
London, United Kingdom
Manchester Royal Eye Hospital
🇬🇧
Manchester, Gt Man, United Kingdom
Hospital Sant Joan de Deu
🇪🇸
Esplugues de Llobregat, Barcelona, Spain
Birmingham and Midland Eye Centre, Consultant Ophthalmologist
🇬🇧
Birmingham, United Kingdom
Fakultni nemocnice Brno
🇨🇿
Brno, Czechia
Ögonkliniken, Centrallasarettet
🇸🇪
Västerås, Sweden
Fondation Ophtalmologique Adolphe de Rothschild
🇫🇷
Paris, Cedex 19, France
Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie
🇧🇪
Edegem, Belgium
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪
Hamburg, Germany
Hospital Clinico San Carlos
🇪🇸
Madrid, Spain
Universitaetsklinikum Mainz
🇩🇪
Mainz, Germany
Universitaetsklinikum Giessen und Marburg
🇩🇪
Giessen, Germany
Rigshospitalet - Glostrup
🇩🇰
Glostrup, Denmark
Azienda Ospedaliero Univ.
🇮🇹
Catania, CT, Italy
Istituto Giannina Gaslini, Divisione di Oculistica
🇮🇹
Genova, Italy
Universitair Ziekenhuis Leuven - Campus Sint-Raphaël
🇧🇪
Leuven, Belgium
Clinica de Oftalmologia San Diego
🇨🇴
Medellin, Antioquia, Colombia
Ospedale Pediatrico Bambino Gesu
🇮🇹
Fiumicino (Roma), Italy
Unita' Operativa di Oculistica Pediatrica, Azienda Ospedaliera Ospedale Niguarda Ca'Grande
🇮🇹
Milano, Italy
AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem
🇵🇹
Coimbra, Portugal
Óptima Visión
🇵🇪
Miraflores, Lima, Peru