Long-Term Non-Interventional Latanoprost Study (LYNX)
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| ClinicalTrials.gov Identifier: NCT01265719 |
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Recruitment Status :
Completed
First Posted : December 23, 2010
Results First Posted : November 5, 2018
Last Update Posted : February 3, 2021
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Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Glaucoma Ocular Hypertension | Other: No intervention other than routine medical care |
| Study Type : | Observational |
| Actual Enrollment : | 175 participants |
| 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 |
| Actual Study Start Date : | December 2010 |
| Actual Primary Completion Date : | February 2016 |
| Actual Study Completion Date : | February 2016 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Latanoprost
| Group/Cohort | Intervention/treatment |
|---|---|
| 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 |
Primary Outcome Measures :
- Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent) [ Time Frame: 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 :
- Number of Participants With Clinically Meaningful Change in Refractive Error [ Time Frame: 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.
- Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler) [ Time Frame: 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) [ Time Frame: 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.
- Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios [ Time Frame: 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.
- Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects. [ Time Frame: 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.
- Iris Color Darkening [ Time Frame: 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.
- Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid [ Time Frame: 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 [ Time Frame: 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.
- Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler) [ Time Frame: 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.
- Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter) [ Time Frame: 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 [ Time Frame: 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
- = 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
- Number of Participants With a Change in Anterior Segment Biomicroscopy [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 1 Day to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| 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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265719
Locations
Show 29 study locations
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| ClinicalTrials.gov Identifier: | NCT01265719 |
| Other Study ID Numbers: |
A6111143 PFI-LAT-2009-01 ( Other Identifier: Alias Study Number ) LYNX ( Other Identifier: Other identifier ) |
| First Posted: | December 23, 2010 Key Record Dates |
| Results First Posted: | November 5, 2018 |
| Last Update Posted: | February 3, 2021 |
| Last Verified: | February 2018 |
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
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Prospective non-interventional longitudinal cohort study |
Additional relevant MeSH terms:
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Ocular Hypertension Eye Diseases |