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

NCT03612817 | Completed Phase 4

• 1 other identifier: 433
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Open-Angle

Keywords

tafluprost/timolol fixed combination, 24-hour IOP control

Outcome Measures

Primary Outcomes (1)

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

  24-hour efficacy documented after each period of therapy

  3-month study

Study Arms (2)

Tafluprost/timolol with PM dosing

ACTIVE COMPARATOR

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

Drug: Tafluprost/timolol fixed combination

Tafluprost/timolol with AM dosing

ACTIVE COMPARATOR

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

Drug: Tafluprost/timolol fixed combination

Interventions

Tafluprost/timolol fixed combination DRUG

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

Also known as: Taptiqom

Tafluprost/timolol with AM dosing; Tafluprost/timolol with PM dosing

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Santen Oy: collaborator

Study Sites (1)

1st University Department of Ophthalmology

Thessaloniki, Makedonia, 54636, Greece

Location

Related Publications (1)

• 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.

  PMID: 30328725 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

tafluprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Theodoros Giannopoulos, MD

  Aristotle University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Only the dosing coordinator is aware of the treatment used.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Ophthalmology

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 2, 2018
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)