CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 661 enrolled
Drug / intervention
Latanoprost-timolol maleate fixed combination ophthalmic solutiondrug
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/NCT01191008
NCT01191008N/ACompleted
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Special Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan)

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·observational·Posted Aug 30, 2010·Updated Jun 1, 2023

In Brief

An observational study evaluating Latanoprost-timolol maleate fixed combination ophthalmic solution for Glaucoma and Ocular Hypertension. Completed, enrolled 661 participants.

Detailed Summary

The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma, Ocular Hypertension
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 15.8 years ago

Interventions

Latanoprost-timolol maleate fixed combination ophthalmic solutiondrug

Xalacom® Combination Eye Drops depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "One drop should be applied to the affected eye(s) once daily".