Clinical Trials Directory

Trials / Completed

CompletedNCT02770248

24-hr Intraocular Pressure Control With SIMBRINZA ®

24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
162 (actual)
Sponsor
Alcon Research · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.

Detailed description

Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.

Conditions

Interventions

TypeNameDescription
DRUGBrinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
DRUGVehicleInactive ingredients used as a placebo for masking purposes

Timeline

Start date
2016-05-23
Primary completion
2017-01-14
Completion
2017-01-14
First posted
2016-05-12
Last updated
2018-07-02
Results posted
2018-01-04

Source: ClinicalTrials.gov record NCT02770248. Inclusion in this directory is not an endorsement.