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. 2025 Jul 7;17(7):e87447.
doi: 10.7759/cureus.87447. eCollection 2025 Jul.

Effectiveness and Safety of Switching to Fixed-Dose, Preservative-Free Tafluprost/Timolol in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: A Real-World Study in Taiwan

Wei-Wen Su  1   2 , Yung-Sung Lee  2   3   4
Affiliations

Effectiveness and Safety of Switching to Fixed-Dose, Preservative-Free Tafluprost/Timolol in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: A Real-World Study in Taiwan

Wei-Wen Su et al. Cureus. .

Abstract

Objective The objective of this study is to evaluate the effectiveness, safety, and tolerability of a preservative-free fixed-dose combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methodology This real-world, prospective, noninterventional study was conducted in Taiwanese patients with OAG or OHT who had an inadequate response or intolerance to topical prostaglandin analogue (PGA) monotherapy and were therefore switched to PF tafluprost/timolol FC. The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to six months after initiating treatment. Changes in clinical signs and subjective symptoms were also evaluated, and adverse events (AEs) were recorded. Results A total of 49 patients were enrolled, and 42 completed the study. The mean ± SD IOP at baseline was 16.5 ± 3.5 mmHg, which significantly decreased to 15.4 ± 3.4 mmHg at six months (absolute reduction: 1.1 ± 2.6 mmHg; p < 0.001). The number of patients with a tear break-up time >10 seconds increased significantly from three (7.5%) at baseline to 22 (52.5%) at six months (p < 0.001). However, a nonsignificant increase was observed in subjective symptoms. Six treatment-related AEs were reported, all of which were nonserious and mild to moderate in severity, including contact dermatitis, redness and itchiness, and blurred vision. Conclusions This real-world, prospective study in Taiwan demonstrated that switching patients with OAG or OHT from PGA monotherapy to PF tafluprost/timolol FC was effective and safe for reducing IOP.

Keywords: fixed-dose combination; glaucoma; ocular hypertension; preservative-free; tafluprost.

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Conflict of interest statement

Human subjects: Informed consent for treatment and open access publication was obtained or waived by all participants in this study. Chang Gung Medical Foundation Institutional Review Board issued approval 202002011A3C501. The study was performed following the current version of the Declaration of Helsinki in agreement with the International Conference on Harmonisation Guidelines on Good Clinical Practice. The study was registered with ClinicalTrials.gov (NCT04828057; registration date: April 1, 2021) and performed in compliance with the requirements of the Linkou Chang Gung Memorial Hospital Medical Center Institutional Review Board. The protocol and informed consent form were approved by the Institutional Review Board on December 24, 2020; revisions were approved on August 21, 2021 (case no. 202002011A3C501). Patient enrollments were started on September 1, 2021, and all patients provided written informed consent to participate in the study prior to study screening activities. Principal Investigator(s): Wei-Wen-Su; Co-Investigator(s): Yung-Sung-Lee; Study Coordinator(s): Shu-hui Yang; Executing Institution: Linkou; Duration of Approval: From 2021/8/21 To 2021/12/15; Date of Approval: 2021/08/21; Frequency of Continuing Report: Once a year; Next Deadline of Continuing Report: 2021/12/15. To facilitate the review, please submit the report two months before the deadline (or one month before the expiration of the trial if a continuing report shall be provided every three months) in order not to influence the principal investigator’s right to conduct the research. In the case that failure or delay to submit a continuing report makes the IRB unable to determine the next trial period by the deadline, the trial shall not be continuously conducted. If the Principal Investigator fails to submit a continuing report on time, rendering the Institutional Review Board unable to issue the next trial execution period before the previous trial execution period expires, all research activities, including the intervention or interaction with the participating trial subjects, must be suspended. Unless the Institutional Review Board considers that the continuation of trial intervention or trial participation is greatly beneficial to the trial subject's safety or in the best interest of the trial subject from a moral point of view, no new trial subject shall be included until the continuing report is formally approved. The IRB is organized and operates in accordance with Good Clinical Practice and the applicable laws and regulations. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1. Study visit schedule
Figure 2
Figure 2. CONSORT flow diagram showing participant flow throughout the study process
* Excluded due to violation of inclusion criteria † Patients diagnosed with COVID-19 missed the 12-week follow-up visit but did not withdraw from the trial ‡ Excluded from the effectiveness analysis set due to discontinuation of treatment before six months and lack of IOP measurement at six months (±30 days) CONSORT: Consolidated Standards of Reporting Trials
Figure 3
Figure 3. Proportion of patients with ≥20% reduction in mean IOP at six months following therapy initiation
IOP: intraocular pressure
Figure 4
Figure 4. Changes in proportions of patients with conjunctival hyperemia severity
Figure 5
Figure 5. Changes in the proportion of patients with CFS scores according to the Oxford grading scale
* At baseline and week 12, patient proportions may not total 100% due to rounding. CFS: corneal fluorescein staining
Figure 6
Figure 6. Changes in proportion of patients across TBUT categories
* At week 4, patient proportions may not total 100% due to rounding.
Figure 7
Figure 7. Changes in the proportion of patients reporting moderate to severe subjective symptoms
See this image and copyright information in PMC

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