Back to results

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

Primary Purpose

Glaucoma, Open-Angle

Status

Completed

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

Tafluprost/timolol fixed combination

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring tafluprost/timolol fixed combination, 24-hour IOP control

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age between 21-85 years;
mild to moderate glaucomatous disc damage and visual field loss (less than -12 dB mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio);
visual acuity greater than 0.1 in the study eye;
open anterior chamber angles;
in each patient the diagnosis of open-angle glaucoma will be made by the principal investigator based on the European Glaucoma Society criteria;
study patients will have to demonstrate a reliable visual field (at least two visual fields with less than 20% fixation losses, false positives, or negatives);
patient should understand the study instructions and to be willing to attend all follow-up appointments and should be willing to comply with study medication usage.

Exclusion Criteria:

previous history of less than 10% IOP decrease on any IOP-lowering medication;
evidence of concurrent conjunctivitis, keratitis, or uveitis in either eye;
history of inadequate adherence; intolerance, or contraindication to either prostaglandins, β-blockers, dorzolamide, or benzalconium chloride (BAK);
severe ocular surface disease, intraocular conventional or laser surgery in the study eye (within 6 months prior to enrolment);
previous history of ocular trauma;
use of corticosteroids (within 3 months before the enrolment) and use of contact lenses;
patients will also be excluded if on baseline exam they show clinical evidence of inflammation, signs of ocular infection (except blepharitis), signs of any corneal abnormality that will affect subsequent IOP measurements;
unwillingness to participate in the trial;
females of childbearing potential or lactating mothers.

Sites / Locations

1st University Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Tafluprost/timolol with PM dosing

Tafluprost/timolol with AM dosing

Arm Description

Therapy with Tafluprost/timolol fixed combination drops dosed PM (20:00)

Therapy with Tafluprost/timolol fixed combination drops dosed AM (08:00)

Outcomes

Primary Outcome Measures

Mean 24-hour pressure control with Tafluprost/timolol fixed combination dosed morning or evening

24-hour efficacy documented after each period of therapy

Secondary Outcome Measures

Full Information

NCT ID

NCT03612817

First Posted

July 20, 2018

Last Updated

December 16, 2020

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Santen Oy

1. Study Identification

Unique Protocol Identification Number

NCT03612817

Brief Title

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

Acronym

TTFC

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aristotle University Of Thessaloniki

Collaborators

Santen Oy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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 Mean efficacy with the evening dosing of tafluprost/timolol compared with the morning-dosed tafluprost/timolol fixed combination at each time point measured. Mean daytime and mean nighttime IOP control with the two dosing regimens. Mean peak and fluctuation of 24-hour pressure with the evening and the morning dosing of the fixed combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle

Keywords

tafluprost/timolol fixed combination, 24-hour IOP control

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

Patients first undergo a baseline, habitual 24-hour pressure assessment with branded, or generic latanoprost. Suitably qualified open-angle glaucoma patients (latanoprost-treated, mean 24-hour pressure greater than 20 mm Hg) are randomized for Period 1 to receive either tafluprost/timolol fixed combination drops once in the evening (20:00) and placebo drops in the morning (08:00), or tafluporst/timolol drops once in the morning (08:00) and placebo in the evening (20:00). After 3 months of chronic therapy (± 2 weeks) study patients undergo a treated, habitual 24-hour pressure assessment. Study subjects are then switched to the opposite treatment regimen for Period 2 (tafluprost/timolol in the evening instead of morning etc) and after another 3 months they undergo the third and final evaluation of their 24-hour pressure.

Masking

Investigator

Masking Description

Only the dosing coordinator is aware of the treatment used.

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tafluprost/timolol with PM dosing

Arm Type

Active Comparator

Arm Description

Therapy with Tafluprost/timolol fixed combination drops dosed PM (20:00)

Arm Title

Tafluprost/timolol with AM dosing

Arm Type

Active Comparator

Arm Description

Therapy with Tafluprost/timolol fixed combination drops dosed AM (08:00)

Intervention Type

Drug

Intervention Name(s)

Tafluprost/timolol fixed combination

Other Intervention Name(s)

Taptiqom

Intervention Description

Evaluation of 24-hour pressure control with tafluprost/timolol given in the evening or morning

Primary Outcome Measure Information:

Title

Mean 24-hour pressure control with Tafluprost/timolol fixed combination dosed morning or evening

Description

24-hour efficacy documented after each period of therapy

Time Frame

3-month study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age between 21-85 years; mild to moderate glaucomatous disc damage and visual field loss (less than -12 dB mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio); visual acuity greater than 0.1 in the study eye; open anterior chamber angles; in each patient the diagnosis of open-angle glaucoma will be made by the principal investigator based on the European Glaucoma Society criteria; study patients will have to demonstrate a reliable visual field (at least two visual fields with less than 20% fixation losses, false positives, or negatives); patient should understand the study instructions and to be willing to attend all follow-up appointments and should be willing to comply with study medication usage. Exclusion Criteria: previous history of less than 10% IOP decrease on any IOP-lowering medication; evidence of concurrent conjunctivitis, keratitis, or uveitis in either eye; history of inadequate adherence; intolerance, or contraindication to either prostaglandins, β-blockers, dorzolamide, or benzalconium chloride (BAK); severe ocular surface disease, intraocular conventional or laser surgery in the study eye (within 6 months prior to enrolment); previous history of ocular trauma; use of corticosteroids (within 3 months before the enrolment) and use of contact lenses; patients will also be excluded if on baseline exam they show clinical evidence of inflammation, signs of ocular infection (except blepharitis), signs of any corneal abnormality that will affect subsequent IOP measurements; unwillingness to participate in the trial; females of childbearing potential or lactating mothers.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Theodoros Giannopoulos, MD

Organizational Affiliation

Aristotle University

Official's Role

Study Director

Facility Information:

Facility Name

1st University Department of Ophthalmology

City

Thessaloníki

State/Province

Makedonia

ZIP/Postal Code

54636

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30328725

Citation

Konstas AG, Katsanos A, Athanasopoulos GP, Voudouragkaki IC, Panagiotou ES, Pagkalidou E, Haidich AB, Giannoulis DA, Spathi E, Giannopoulos T, Katz LJ. Preservative-free tafluprost/timolol fixed combination: comparative 24-h efficacy administered morning or evening in open-angle glaucoma patients. Expert Opin Pharmacother. 2018 Dec;19(18):1981-1988. doi: 10.1080/14656566.2018.1534958. Epub 2018 Oct 17.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs