Preservative-free tafluprost/timolol fixed combination: comparative 24-h efficacy administered morning or evening in open-angle glaucoma patients

ABSTRACT

Background

Ideal dosing for the preservative-free (PF) tafluprost/timolol fixed combination (TTFC) remains to be elucidated.

Research design and methods

This study was a prospective, observer-masked, placebo-controlled, crossover, comparison in 42 consecutive open-angle glaucoma patients whose intraocular pressure (IOP) was insufficiently controlled with preserved latanoprost monotherapy (mean 24-h IOP >20 mmHg). Patients were randomized to either morning (08:00) or evening (20:00) PF TTFC for 3 months and then crossed over. After each treatment period, patients underwent habitual 24-h IOP 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).

Results

Mean 24-h IOP on latanoprost was 22.2±3.9 mmHg. Both PF TTFC dosing regimens obtained greater reduction in mean 24-h, daytime, nighttime, and peak 24-h IOP (P < 0.001). Evening dosing provided tighter 24-h IOP fluctuation versus latanoprost (P < 0.001). Evening dosing was superior to morning dosing at four time points (P < 0.01), for the mean daytime IOP (P < 0.001) and mean 24-h IOP fluctuation (P < 0.001). Hyperemia was more common with preserved latanoprost (21.4 vs. 7.1%; P = 0.031). Patients (n = 19; 45%) preferred evening dosing.

Conclusions

PF TTFC provided greater 24-h IOP control and less hyperemia compared with preserved latanoprost. Evening administration of this novel medication offered superior 24-h efficacy.

Trial registration

Clinicaltrials.gov (NCT03612817)

KEYWORDS:

• 24-h efficacy
• BAK
• hyperemia
• latanoprost
• preservative-free tafluprost/timolol fixed combination
• tafluprost
• Taptiqom

Declaration of interest

AG Konstas has received research support from Allergan, Bayer Hellas, Novartis, Pharmathen Hellas S.A. and Santen as well as honoraria from Allergan, Novartis, Santen and had congress expenses covered by Allergan, Bayer Hellas, Santen and Vianex. A Katsanos has received honoraria from Allergan, Laboratoires Théa, Novartis, Vianex and had congress expenses covered by Laboratoires Théa and Vianex. GP Athanasopoulos has received congress and course expenses from Allergan, Bayer Hellas and Maxyn S.a.. IC Voudouragkaki had congress expenses covered by Bayer Hellas and Vianex. T Giannopoulos has received research support from Bayer Hellas, Pharmathen Hellas S.A. and had congress expenses covered by Bayer Hellas and Novartis. LJ Katz has received grant/research support from Allergan, Diopsys, Heidelberg Engineering and Alcon. He is also a consultant/advisory board member of Allergan, Alcon, Glaukos and Aerie Pharmaceuticals and has received consulting fees from Diopsys, Mati Therapeutics and Aerpio Therapeutics. Furthermore, Professor Katz has been a speaker for Allergan, Alcon, Glaukos and Bausch & Lomb and has received honoraria from Aerie Pharmaceuticals. Additionally, he is a stock shareholder of Glaukos, Mati Therapeutics and Aerie Pharmaceuticals and is a Chief Medical Officer of Glaukos. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. No medical writing or editorial assistance was received for this manuscript. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. Prof. Konstas is the guarantor for this article, and takes responsibility for the integrity of the work as a whole.

Additional information

Funding

The current study was funded in part by Santen.