NCT01265719

Long-Term Non-Interventional Latanoprost Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 175 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2010-12-23
• Last updated: 2021-02-03
• Results posted: 2018-11-05

Locations

29 sites across 14 countries: Belgium, Colombia, Czechia, Denmark, France, Germany, Greece, Italy, Peru, Portugal, Slovakia, Spain, Sweden, United Kingdom