Clinical Ophthalmology (Jun 2024)

24-Hour Evaluation of the Effectiveness and Tolerability of Preservative-Free Tafluprost-Timolol Fixed Combination in Open-Angle Glaucoma or Ocular Hypertensive Patients Previously Treated with Preserved Latanoprost

  • Oddone F,
  • Tanga L,
  • Giammaria S,
  • Sabbatini L,
  • Strianese A,
  • Ferrazza M,
  • Rossetti LM

Journal volume & issue
Vol. Volume 18
pp. 1751 – 1760

Abstract

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Francesco Oddone,1 Lucia Tanga,1 Sara Giammaria,1 Lorenzo Sabbatini,2 Alfonso Strianese,2 Manuela Ferrazza,1 Luca Mario Rossetti2 1IRCCS - Fondazione Bietti, Rome, Italy; 2Eye Clinic, ASST Santi Paolo E Carlo, University of Milan, Milan, ItalyCorrespondence: Francesco Oddone, Glaucoma Unit IRCCS Fondazione Bietti, Via Livenza 3, Roma, 00198, RM, Italy, Tel +39-06-85356727 ; +39-3291921575, Email [email protected]: The effectiveness, safety and tolerability of the preservative-free fixed combination of tafluprost and timolol (PF-TTFC) were evaluated over the 24-h in patients with open-angle glaucoma or ocular hypertension showing signs and symptoms of Ocular Surface Disease (OSD) and uncontrolled intraocular pressure (IOP) on prior benzalkonium chloride (BAK) – Latanoprost monotherapy.Methods: In this multi-center, prospective, interventional, non-comparative clinical trial, patients treated with BAK-Latanoprost underwent 24-h IOP measurements (8 am, 11 am, 2 pm, 5 pm, 8 pm, 11 pm, 2 am, 5 am) at baseline and after 3 months from switch to PF-TTFC. Mean 24-h IOP and daytime (8 am– 8 pm) vs nighttime (11 pm – 5 am) IOP were compared. Changes in OSD signs and symptoms, quality of life (QoL) and in-vivo corneal confocal microscopy (IVCM) were also evaluated.Results: Thirty-eight patients were analyzed. The mean 24-h IOP significantly decreased after 3 months from 17.8 mmHg (95% CI: 17.1– 18.6) to 15.3 mmHg (95% CI: 14.6– 16.1, p < 0.001). IOP was significantly reduced both at daytime (p < 0.001) and nighttime (p < 0.001), with better IOP control at night [− 2.9 (95% CI: − 3.5 to − 2.1) mmHg vs − 2.3 (95% CI: − 2.9 to − 1.6) mmHg]. In 20 patients (52.6%), corneal fluorescein staining improved, whereas in 4 patients (10.5%) it worsened. Hyperemia has improved in 24 (63.3%) patients and worsened in 2 (5.3%). Breakup time, Schirmer test and QoL scores showed no changes. At IVCM, the mean corneal wing-cell size was found significantly decreased (p < 0.005).Conclusion: The switch from BAK-Latanoprost to PF-TTFC significantly reduced IOP over the 24-h and improved OSD signs and symptoms.Keywords: glaucoma, tafluprost-timolol fixed combination, preservative free, BAK, prostaglandins, 24-h effectiveness, ocular surface disease

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