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. 2014 Feb 3:8:347-54.
doi: 10.2147/OPTH.S57640. eCollection 2014.

Travoprost with sofZia® preservative system lowered intraocular pressure of Japanese normal tension glaucoma with minimal side effects

Shiro Mizoue  1 , Tadashi Nakano  2 , Nobuo Fuse  3 , Aiko Iwase  4 , Shun Matsumoto  5 , Keiji Yoshikawa  6
Affiliations

Travoprost with sofZia® preservative system lowered intraocular pressure of Japanese normal tension glaucoma with minimal side effects

Shiro Mizoue et al. Clin Ophthalmol. .

Abstract

Background: This study aimed to evaluate the effect of travoprost with sofZia® preservative system for lowering the intraocular pressure (IOP) of Japanese normal tension glaucoma (NTG) patients.

Methods: In this prospective, multicenter, open-label study, Japanese NTG patients with baseline IOPs <20 mmHg were enrolled after three consecutive time measurements taken at screening and baseline visits. Travoprost with sofZia® was instilled once daily. Lowering effect on IOP, conjunctival hyperemia, superficial punctate keratopathy, and adverse events were examined at week 4, 8, and 12 after drug instillation.

Results: One-hundred and three of the 107 enrolled patients (baseline IOP =15.2±2.0 mmHg [mean ± standard deviation]) completed the study. The mean IOP value as well as percent reduction was significantly reduced at each visit after travoprost with sofZia® initiation (P<0.0001). The conjunctival hyperemia score was 1 or less throughout the study, though it increased significantly over time. No significant change was observed in superficial punctate keratopathy. The cumulative incidence of side effects such as eyelash changes, eyelid pigmentation, and deepening of the upper lid was 47.6%, 27.2%, and 16.5%, respectively.

Conclusion: Travoprost preserved with sofZia® effectively lowered the IOP of Japanese NTG patients. It was well tolerated with few discontinuations due to adverse events.

Keywords: normal tension glaucoma (NTG); prostaglandin analogue; travoprost with sofZia® preservative system.

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Figures

Figure 1
Figure 1
IOP before and after travoprost with sofZia® administration. Notes: IOP is presented as the mean ± SD. *P<0.0001 for significant change of IOP compared with baseline by repeated measures analysis of variance and multiple comparison using Tukey’s HSD test. sofZia® (Travatan® 0.004%, Alcon Laboratories, Inc., Fort Worth, TX, USA). Abbreviations: HSD, honestly significant difference; IOP, intraocular pressure; SD, standard deviation.
Figure 2
Figure 2
Percentage reduction of IOP with drug administration. Notes: IOP reduction rates are classified into four categories represented by each column: ≥30%, ≥20%, ≥10%, <10%. Open circle ( ) represents the mean ± SD. Vertical axes: Left and right axes represent cumulative and average percentage reduction of IOP, respectively. Abbreviations: IOP, intraocular pressure; SD, standard deviation.
Figure 3
Figure 3
Change of IOP in three groups with drug administration. Notes: Eyes were classified into three groups based on their baseline IOP: ○ ≥17 mmHg, ● ≥14 mmHg and 17 mmHg, × <14 mmHg. *P<0.0001 for significant change of IOP compared with each baseline by repeated measures analysis of variance and multiple comparison using Tukey’s HSD test. Abbreviations: HSD, honestly significant difference; IOP, Intraocular pressure.
Figure 4
Figure 4
Cumulative incidence of subjective symptoms. Notes: The cumulative incidence of adverse events in this study was 40.8% (by week 12). The most frequently observed event was ocular irritation [○: 26.2%, n=27], itching (●: 18.5%, n=19), foreign body sensation (×: 17.5%, n=18) and dryness (∆: 4.9%, n=5).
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References

    1. Netland PA, Landry T, Sullivan EK, et al. Travoprost Study Group Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2001;132(4):472–484. - PubMed
    1. Lewis RA, Katz G, Weiss MJ, et al. Travoprost BAC-free Group Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy. J Glaucoma. 2007;16(1):98–103. - PubMed
    1. Iwase A, Suzuki Y, Araie M, et al. Tajimi Study Group, Japan Glaucoma Society The prevalence of primary open-angle glaucoma in Japanese: the Tajimi Study. Ophthalmology. 2004;111(9):1641–1648. - PubMed
    1. Klein BE, Klein R, Sponsel WE, et al. Prevalence of glaucoma: The Beaver Dam Eye Study. Ophthalmology. 1992;99(10):1499–1504. - PubMed
    1. Bonomi L, Marchini G, Marraffa M, et al. Prevalence of glaucoma and intraocular pressure distribution in a defined population. The Egna-Neumarkt Study. Ophthalmology. 1998;105(2):209–215. - PubMed

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