Efficacy and tolerability of preservative-free 0.0015% tafluprost in glaucoma patients: a prospective crossover study

Wonseok Lee, Sunghoon Lee, HyoungWon Bae, Chan Yun Kim, Gong Je Seong, Wonseok Lee, Sunghoon Lee, HyoungWon Bae, Chan Yun Kim, Gong Je Seong

Abstract

Background: The aim of this work is to evaluate efficacy and tolerability of preservative containing 0.0015% tafluprost and preservative-free 0.0015% tafluprost using a prospective crossover study.

Methods: Primary open angle glaucoma (POAG) and normotensive glaucoma (NTG) patients were randomized enrolled. Group 1 ("NPT to PT") patients used preservative-free 0.0015% tafluprost (NPT) for 6 months and then changed to preservative containing 0.0015% tafluprost(PT) for 6 months. Group 2 ("PT to NPT") patients used preservative containing 0.0015% tafluprost for 6 months and changed to preservative-free 0.0015% tafluprost for 6 months. At 1, 3, 6, 7, 9, and 12 months, we measured intraocular pressure for efficacy and graded corneal erosion, tear break-up time (TBUT), and subjective discomfort.

Results: A total of 20 patients and 20 eyes were enrolled. In Group 1 and 2, intraocular pressure was well controlled to approximately 14 mmHg (9.38-18.46% decrease). Generally, subjective satisfaction was improved after changing from PT to NPT (p = 0.03) and TBUT using PT was numerically inferior to that using NPT (p = 0.06) but not when changing from NPT to PT.

Conclusion: Both preservative containing and preservative-free 0.0015% tafluprost reduced intraocular pressure significantly. In addition, changing medication from PT to NPT might improve subjective satisfaction and tear break up time.

Trial registration: The trial registration number is NCT 03104621 (Apr/1/2017). Retrospectively registered.

Trial registration: ClinicalTrials.gov NCT03104621.

Keywords: Efficacy; Preservative; Tafluprost; Tolerability.

Figures

Fig. 1
Fig. 1
(a) Corneal erosion grade 0; Little to no erosion (b) Corneal erosion grade 1; erosion on lower than 1/3 of the area of the entire cornea (c) Corneal erosion grade 2; erosion on 1/3 to 2/3 of the area of the entire cornea (d) Corneal erosion grade 3; erosion on the nearlyentire cornea
Fig. 2
Fig. 2
Intraocular pressure (IOP) before and after using 0.0015% tafluprost. Indicated numbers are the means of intraocular pressure before using tafluprost and after 1, 3, 6, 7, 9, and 12 months of use. 1 month after using tafluprost, IOP was well maintained for 12 month. (* : p < 0.001, # : p > 0.05)
Fig. 3
Fig. 3
Subjective discomfort in Group 1 (NPT → PT) and Group 2 (PT → NPT). Before exchanging product (6 m) and after 6 month (12 m), the reduction of score was significant in Group 2. (p = 0.03)
Fig. 4
Fig. 4
Corneal erosion grade in Group 1 (NPT → PT) and Group 2 (PT → NPT). Corneal erosion was increased using PT, but it was not statistically significant
Fig. 5
Fig. 5
The results of Schirmer test in Group 1 (NPT → PT) and Group 2 (PT → NPT)
Fig. 6
Fig. 6
The results of tear break up time (TBUT) in Group 1 (NPT → PT) and Group 2 (PT → NPT). Comparison between baseline TBUT and after 12 months of treatment showed a slightly decreased TBUT in Group 1 (NPT → PT). (p = 0.06)

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