Status:
COMPLETED
Long-Term Non-Interventional Latanoprost Study
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
1-17 years
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...
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 Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT01265719
Start Date
December 1 2010
End Date
February 1 2016
Last Update
February 3 2021
Active Locations (29)
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1
Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie
Edegem, Belgium, 2650
2
Universitair Ziekenhuis Leuven - Campus Sint-Raphaël
Leuven, Belgium, 3000
3
Clinica de Oftalmologia San Diego
Medellín, Antioquia, Colombia, 050016
4
Fakultni nemocnice Brno
Brno, Czechia, 613 00