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Preservative-free Tafluprost/Timolol Fixed Combination: Morning vs Evening Dosing — TTFC  

Glaucoma, Open-Angle Clinical Trial

Official title:
A 3-month Study Investigating the 24-hour Efficacy With the Preservative-free Tafluprost/Timolol Fixed Combination Dosed Morning, or Evening in Subjects With Open-angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy

Clinical Trial Summary

The ideal dosing for preservative-free tafluprost/timolol fixed combination remains to be elucidated. The present study compared the 24-hour intraocular pressure efficacy obtained with tafluprost/timolol given once in the evening with placebo once in the morning, versus that with the same fixed combination administered once in the morning with placebo given once in the evening in consecutive patients with open-angle glaucoma insufficiently controlled with branded, or generic latanoprost monotherapy.

Clinical Trial Description

Prospective, observer-masked, placebo-controlled, crossover, comparison in consecutive open-angle glaucoma patients, insufficiently controlled with preserved latanoprost monotherapy (mean 24-hr IOP greater than 20 mmHg). Patients were randomized to either morning (08:00), or evening (20:00) preservative-free tafluprost/timolol fixed combination for 3 months and then were crossed over. After each treatment period patients underwent habitual 24-hour intraocular pressure monitoring with Goldmann tonometry in the sitting position (at 10:00, 14:00, 18:00 and 22:00) and Perkins tonometry in the supine position (at 02:00 and 06:00). Primary Study Objective: Mean 24-hour efficacy with both dosing regimens of tafluprost/timolol fixed combination versus latanoprost monotherapy. Secondary Study Objectives 1. Mean efficacy with the evening dosing of tafluprost/timolol compared with the morning-dosed tafluprost/timolol fixed combination at each time point measured. 2. Mean daytime and mean nighttime IOP control with the two dosing regimens. 3. Mean peak and fluctuation of 24-hour pressure with the evening and the morning dosing of the fixed combination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03612817
Study type Interventional
Source Aristotle University Of Thessaloniki
Contact
Status Completed
Phase Phase 4
Start date January 2017
Completion date July 2018
View Details
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