CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 175 enrolled
Drug / intervention
No intervention other than routine medical care +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01265719
NCT01265719N/ACompleted

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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·observational·Posted Dec 23, 2010·Updated Feb 3, 2021

In Brief

An observational study evaluating No intervention other than routine medical care for Glaucoma and Ocular Hypertension. Completed, enrolled 175 participants across 29 sites in 14 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Colombia, Czechia, Denmark, France, Germany, Greece, Italy, Peru, Portugal, Slovakia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2010
Enrollment StartDec 1, 2010
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 15.5 years ago

Interventions

No intervention other than routine medical careother

Subjects continuously treated with Latanoprost for at least one month Latanoprost treatment during the study period.

No intervention other than routine medical careother

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.