Journal name: Clinical Ophthalmology
`Article Designation: Original Research
`Year: 2016
`Volume: 10
`Running head verso: Ikeda et al
`Running head recto: Comparison between latanoprost and tafluprost
`DOI: http://dx.doi.org/10.2147/OPTH.S108213
`
`Clinical Ophthalmology
`
`Open access Full Text article
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`open access to scientific and medical research
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`O r i g i n a l re s e a rCh
`
`Comparison study of intraocular pressure
`reduction efficacy and safety between latanoprost
`and tafluprost in Japanese with normal-tension
`glaucoma
`
`Yoko ikeda 1,2,*
`Kazuhiko Mori1,*
`Kaori Tada3
`Morio Ueno1
`shigeru Kinoshita 4
`Chie sotozono 1
`1Department of Ophthalmology,
`Kyoto Prefectural University of
`Medicine, 2Oike-Ganka Ikeda Clinic,
`3Department of Ophthalmology,
`Japanese Red Cross Society Kyoto
`Daini hospital, 4Department of
`Frontier Medical science and
`Technology for Ophthalmology, Kyoto
`Prefectural University of Medicine,
`Kyoto, Japan
`
`*These authors contributed equally
`to this work
`
`Correspondence: Kazuhiko Mori
`Department of Ophthalmology, Kyoto
`Prefectural University of Medicine, 465
`Kajii-cho, Hirokoji-agaru, Kawaramachi-
`dori, Kamigyo-ku, Kyoto 602-0841, Japan
`Tel +81 75 251 5578
`Fax +81 75 251 5663
`email kmori@koto.kpu-m.ac.jp
`
`submit your manuscript | www.dovepress.com
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`http://dx.doi.org/10.2147/OPTH.S108213
`
`Purpose: To evaluate and compare the intraocular pressure (IOP) reduction efficacy and safety
`between the ophthalmic solutions 0.005% latanoprost (Lat) and 0.0015% tafluprost (Taf) in
`Japanese patients with normal-tension glaucoma (NTG).
`Methods: In this randomized nonmasked study, we prospectively enrolled 30 Japanese
`NTG patients who had used Lat monotherapy for more than 4 weeks, and randomly divided
`them into the following two groups: 1) Lat-to-Taf group (LT group) and 2) Taf-to-Lat group
`(TL group). At the beginning of the study, both groups were switched from initial Lat to Lat or
`Taf for 12 weeks, and then switched over to the other drug (crossover) for 12 additional weeks.
`At 0, 4, 12, 16, and 24 weeks, we evaluated each patient’s IOP, conjunctival injection, and
`corneal epitheliopathy score, and at 0, 12, and 24 weeks, we evaluated their eyelash changes
`and pigmentation of the eyelids and irises.
`Results: The mean IOP of the LT group (15 eyes) was 10.5, 10.6, and 11.1 mmHg, at 0, 12, and
`24 weeks, respectively, whereas that of the TL group (15 eyes) was 11.7, 11.1, and 10.5 mmHg
`at 0, 12, and 24 weeks, respectively. No significant differences were found between the two
`groups and in the intragroup comparisons. Moreover, no significant differences were found
`between Lat and Taf in regard to the conjunctival injection score and corneal epitheliopathy
`score. Eyelash changes and eyelid and iris pigmentation were similar in both groups.
`Conclusion: The findings of this study show that Lat and Taf have equivalent efficacy and
`safety in Japanese patients with NTG.
`Keywords: latanoprost, tafluprost, normal-tension glaucoma, crossover
`
`Introduction
`Glaucoma is one of the major leading causes of blindness worldwide.1 In Japan,
`glaucoma has become the primary cause of blindness since 2004.2 Normal-tension
`glaucoma (NTG) is the most common type of glaucoma in Japan,3 with a prevalence rate
`of 3.6% in people over 40 years of age. The ophthalmic solutions 0.005% latanoprost
`(Lat)4,5 and 0.0015% tafluprost (Taf)6,7 are topical prostaglandin analogs. Both solu-
`tions greatly reduce intraocular pressure (IOP) by increasing the uveoscleral outflow
`as a prostaglandin F receptor agonist.8 Lat was first approved for clinical use in 1996
`and has been used globally since then as a first-line drug for the treatment of glau-
`coma. On the other hand, the IOP reduction efficacy and safety of Taf, first launched
`in 2008, is reportedly equivalent to that of Lat9 for patients with primary open-angle
`glaucoma or ocular hypertension. Although there have been reports on the efficacy
`
`1633
`Clinical Ophthalmology 2016:10 1633–1637
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`hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission
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`ikeda et al
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`of Taf for NTG patients,10,11 to the best of our knowledge,
`no comparison crossover studies have been conducted to
`investigate the efficacy and safety between Lat and Taf for
`NTG patients.
`In this prospective crossover study involving Japanese
`NTG patients, the IOP reduction efficacy and safety of Taf
`were compared with those of Lat.
`
`Subjects and methods
`All study procedures were approved by the Institutional
`Review Board of Kyoto Prefectural University of Medicine,
`Kyoto, Japan, and were performed in accordance with the
`tenets set forth in the Declaration of Helsinki. This study
`was a randomized nonmasked study. All study participants
`were recruited between March 2009 and March 2011. We
`selected and enrolled 30 Japanese NTG patients who had
`used Lat monotherapy at least 4 weeks at the Glaucoma
`Special Clinic of Kyoto Prefectural University of Medicine.
`Written informed consent was obtained from all patients after
`receiving a detailed explanation of the nature and possible
`consequences of their participation in the study.
`Each of the 30 enrolled patients were randomly divided
`into one of the following two groups: 1) Lat-to-Taf group
`(LT group: 15 patients, 7 male eyes and 8 female eyes; mean
`age: 63.5±11.5 years) and 2) Taf-to-Lat group (TL group:
`15 patients, 8 male eyes and 7 female eyes; mean age:
`69.1±8.8 years). At the beginning of the study, both groups
`were switched from initial Lat to Lat or Taf for 12 weeks,
`and then switched over to the other drug (crossover) to use
`for 12 additional weeks (Figure 1). At 0, 4, 12, 16, and
`24 weeks, we evaluated their IOP, conjunctival injection
`score (Grades 0–3),12 and corneal epitheliopathy score
`(area density [AD] score).13 Then, at 0, 12, and 24 weeks, we
`evaluated adverse events of eyelash changes and pigmenta-
`tion of the eyelids and irises via a slit-lamp photograph taken
`at each visit. The incidence of eyelash and pigmentation
`was judged via slit-lamp photographs, with a comparison
`
`(cid:20)(cid:21)(cid:3)(cid:90)(cid:72)(cid:72)(cid:78)(cid:86)
`(cid:55)(cid:68)(cid:73)(cid:3)(cid:87)(cid:85)(cid:72)(cid:68)(cid:87)(cid:72)(cid:71)
`
`(cid:20)(cid:21)(cid:3)(cid:90)(cid:72)(cid:72)(cid:78)(cid:86)
`(cid:55)(cid:68)(cid:73)(cid:3)(cid:87)(cid:85)(cid:72)(cid:68)(cid:87)(cid:72)(cid:71)
`
`(cid:55)(cid:68)(cid:73)(cid:3)(cid:82)(cid:85)(cid:3)(cid:47)(cid:68)(cid:87)(cid:3)(cid:87)(cid:85)(cid:72)(cid:68)(cid:87)(cid:72)(cid:71)
`
`(cid:47)(cid:68)(cid:87)(cid:3)(cid:87)(cid:85)(cid:72)(cid:68)(cid:87)(cid:72)(cid:71)
`
`(cid:23)(cid:3)(cid:90)(cid:72)(cid:72)(cid:78)(cid:86)
`
`(cid:47)(cid:68)(cid:87)(cid:3)(cid:87)(cid:85)(cid:72)(cid:68)(cid:87)(cid:72)(cid:71)
`
`(cid:47)(cid:68)(cid:87)(cid:3)(cid:87)(cid:85)(cid:72)(cid:68)(cid:87)(cid:72)(cid:71)
`
`(cid:20)(cid:21)(cid:58) (cid:20)(cid:25)(cid:58)
`(cid:19)(cid:58) (cid:23)(cid:58)
`(cid:48)(cid:72)(cid:68)(cid:86)(cid:88)(cid:85)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:44)(cid:50)(cid:51)
`
`(cid:21)(cid:23)(cid:58)
`
`Figure 1 study design.
`Abbreviations: IOP, intraocular pressure; Taf, tafluprost; Lat, latanoprost; W, week.
`
`between the current and baseline photographs. In all patients,
`IOP was measured by using an applanation tonometer
`(H03 R 90030515; Haag-Streit, Bern, Switzerland) by the
`same glaucoma specialist throughout the protocol periods,
`and those IOP measurements were obtained at approximately
`the same time of day for each patient. If data were available
`from both eyes, then the right-eye data were used. We evalu-
`ated the mean deviation of the Humphrey 30-2 threshold of
`static visual field program at baseline or within 3 months.
`Statistical analysis was performed using the Student’s t-test
`and Fisher’s exact test.
`For each patient, Lat and Taf eye drops were prescribed
`at the Glaucoma Special Clinic. As this was not a masked
`study, both the patient and the doctor knew which eye drop
`was being used. A calculated sample size of 15 enrolled
`subjects per arm providing the power of 80% was based on
`a noninferiority limit of 1.5 mmHg, a standard deviation of
`1.5 mmHg for change in IOP.
`
`Results
`There were no dropout cases, and all patients completed the
`study. Of the total 30 subjects, 28 were newly prescribed Lat,
`yet 1 subject in both the LT and TL groups used Lat for more
`than 4 weeks. The backgrounds of the patients are detailed
`in Table 1. There were no significant differences in age, sex
`ratio, or mean deviation obtained from Humphrey perimetry
`sita standard 30-2 between the LT and TL groups.
`As for the IOP time course of all subjects, at 0, 12,
`and 24 weeks, respectively, the mean IOP of the LT group
`(15 eyes) was 10.5, 10.6, and 11.1 mmHg, whereas that of
`the TL group (15 eyes) was 11.7, 11.1, and 10.5 mmHg,
`and no significant differences were found between the two
`groups (Student’s t-test) (Figure 2). At 0, 4, and 12 weeks,
`respectively, the mean IOP of the Lat intragroup (30 eyes)
`was 10.8, 10.6, and 10.5 mmHg, whereas that of the Taf
`
`Table 1 Background of the subjects
`All subjects LT group TL group
`30
`15
`15
`15/15
`7/8
`8/7
`66.3±10.5
`69.1±8.8
`63.5±11.5
`11.1±2.0
`10.5±1.7
`11.7±2.2
`
`Number of subjects
`Male/female
`Mean age (years)
`Baseline iOP at study starting
`(mmhg)
`Nonmedication baseline IOP
`(mmhg)
`Baseline MD (dB)
`Periods of Lat use before
`initiation of this study (weeks)
`Note: Data presented as mean ± sD.
`Abbreviations: LT, latanoprost to tafluprost; TL, tafluprost to latanoprost;
`iOP, intraocular pressure; MD, mean deviation; lat, latanoprost.
`
`13.8±2.2
`
`13.9±2.3
`
`13.6±2.0
`
`−4.2±42
`5.5±8.2
`
`−4.5±5.2
`6.9±11.4
`
`−3.9±3.3
`22.9±73.3
`
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`Comparison between latanoprost and tafluprost
`
`(cid:19)(cid:20)(cid:21)(cid:22)
`
`(cid:54)(cid:70)(cid:82)(cid:85)(cid:72)
`
`(cid:49)(cid:54)
`
`(cid:55)(cid:47)(cid:3)(cid:74)(cid:85)(cid:82)(cid:88)(cid:83)
`(cid:47)(cid:55)(cid:3)(cid:74)(cid:85)(cid:82)(cid:88)(cid:83)(cid:3)
`
`(cid:20)(cid:27)
`
`(cid:20)(cid:24)
`
`(cid:20)(cid:21)
`
`(cid:44)(cid:50)(cid:51)(cid:3)(cid:80)(cid:80)(cid:43)(cid:74)
`
`(cid:19)
`
`(cid:25)(cid:28)
`
`(cid:23)
`
`(cid:27)
`
`(cid:20)(cid:25)
`
`(cid:21)(cid:19)
`
`(cid:21)(cid:23)
`
`(cid:20)(cid:21)
`(cid:58)(cid:72)(cid:72)(cid:78)(cid:86)
`Figure 2 IOP time course of all subjects.
`Note: No significant difference in IOP reduction was found between the LT to TL
`group and the Tl to lT group throughout 24 months.
`Abbreviations: IOP, intraocular pressure; LT, latanoprost to tafluprost; TL,
`tafluprost to latanoprost; NS, not significant.
`
`(cid:19)
`
`(cid:23)
`
`(cid:27)
`
`(cid:20)(cid:25)
`
`(cid:21)(cid:19)
`
`(cid:21)(cid:23)
`
`(cid:20)(cid:21)
`(cid:58)(cid:72)(cid:72)(cid:78)(cid:86)
`Figure 4 Conjunctival hyperemia score.
`Note: No significant difference in conjunctival hyperemia score was found between
`the two groups.
`Abbreviations: LT, latanoprost to tafluprost; TL, tafluprost to latanoprost; NS,
`not significant.
`
`(cid:55)(cid:47)(cid:3)(cid:74)(cid:85)(cid:82)(cid:88)(cid:83)
`(cid:47)(cid:55)(cid:3)(cid:74)(cid:85)(cid:82)(cid:88)(cid:83)(cid:3)
`
`(cid:49)(cid:54)
`
`intragroup (30 eyes) was 10.8, 10.7, and 11.1 mmHg, and
`no significant differences were found between the two intra-
`groups (Student’s t-test) (Figure 3).
`The mean conjunctival hyperemia score at 0, 4, 12, 16,
`and 24 weeks, respectively, was 1.0±0.4, 1.0±0.5, 0.9±0.3,
`0.9±0.4, and 0.9±0.4 in the LT group and 1.0±0.4, 1.1±0.5,
`1.1±0.6, 1.0±0.5, and 1.1±0.5 in the TL group, and no signifi-
`cant differences were found between two groups (Student’s
`t-test) (Figure 4). The respective mean AD score at 0, 4, 12,
`16, and 24 weeks was 0.5±0.9, 1.0±1.4, 0.7±1.0, 0.9±1.4,
`and 0.7±1.0 in the LT group and 1.0±1.3, 0.7±1.0, 0.7±1.0,
`0.5±1.0, and 0.8±1.3 in the TL group, and no significant
`differences were found between the two groups (Student’s
`t-test) (Figure 5).
`The rates of the adverse events of eyelash change and
`eyelid and iris pigmentation induced by Lat or Taf are shown
`in Table 2. The incidence of eyes showing increased eyelash
`length was 30.0% by Lat and 26.7% by Taf, and the incidence
`of eyes showing increased eyelash amount was 16.7% by Lat
`and 30.0% by Taf. The incidence of eyes showing increased
`eyelid pigmentation was 3.3% by Lat and 20.0% by Taf, and
`
`the incidence of eyes showing increased iris pigmentation
`was 6.7% by Lat and 3.3% by Taf. There was no significant
`difference in the incidence of eyelash change (length and
`amount) as well as eyelid and iris pigmentation between the
`two groups (Fisher’s exact test).
`
`Discussion
`Although there have been reports on the efficacy of Taf for
`NTG patients, to the best of our knowledge, this present study
`is the first crossover prospective report to investigate and
`compare IOP reduction efficacy and safety between Lat and
`Taf in NTG patients. In this study, no significant differences
`were found between Lat and Taf in regard to IOP reduction
`effects, conjunctival hyperemia score, and corneal epithe-
`liopathy score, as well as eyelash change and eyelid and iris
`pigmentation. It has been reported that conjunctival hyper-
`emia becomes stronger when switching from Lat to travoprost
`or bimatoprost,14,15 and the same tendency was found to be
`true in this present study when switching from Lat to Taf.
`Although there were no statistically significant differences,
`elongation of eyelash length was more frequently found in
`
`(cid:36)(cid:79)(cid:79)(cid:3)(cid:72)(cid:92)(cid:72)(cid:86)(cid:3)(cid:87)(cid:85)(cid:72)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:55)(cid:68)(cid:73)
`(cid:36)(cid:79)(cid:79)(cid:3)(cid:72)(cid:92)(cid:72)(cid:86)(cid:3)(cid:87)(cid:85)(cid:72)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:47)(cid:68)(cid:87)
`
`(cid:20)(cid:27)
`
`(cid:20)(cid:24)
`
`(cid:20)(cid:21)
`
`(cid:44)(cid:50)(cid:51)(cid:3)(cid:80)(cid:80)(cid:43)(cid:74)
`
`(cid:25)(cid:28)
`
`(cid:19)
`
`(cid:23)(cid:27)
`
`(cid:20)
`
`(cid:21)
`
`(cid:58)(cid:72)(cid:72)(cid:78)(cid:86)
`Figure 3 IOP reduction time-course between all subjects of the Lat and Taf group.
`Note: No significant difference in IOP reduction was found between the two groups.
`Abbreviations: IOP, intraocular pressure; Lat, latanoprost; Taf, tafluprost; NS, not
`significant.
`
`(cid:55)(cid:47)(cid:3)(cid:74)(cid:85)(cid:82)(cid:88)(cid:83)
`(cid:47)(cid:55)(cid:3)(cid:74)(cid:85)(cid:82)(cid:88)(cid:83)(cid:3)
`
`(cid:49)(cid:54)
`
`(cid:36)(cid:39)(cid:3)(cid:86)(cid:70)(cid:82)(cid:85)(cid:72)
`
`(cid:49)(cid:54)
`
`(cid:22)
`(cid:21)(cid:17)(cid:24)
`(cid:21)
`(cid:20)(cid:17)(cid:24)
`(cid:20)
`(cid:19)(cid:17)(cid:24)
`(cid:19)
`
`(cid:19)
`
`(cid:23)(cid:27)
`
`(cid:20)
`
`(cid:20)(cid:25)
`
`(cid:21)(cid:19)
`
`(cid:21)(cid:23)
`
`(cid:21)
`(cid:58)(cid:72)(cid:72)(cid:78)(cid:86)
`Figure 5 Corneal epitheliopathy score (aD score).
`Note: No significant difference in AD score was found between the two groups.
`Abbreviations: AD, area density; LT, latanoprost to tafluprost; TL, tafluprost to
`latanoprost; NS, not significant.
`
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`Table 2 incidence of eyes showing increased eyelash and
`incidence of eyes showing increased pigmentation at 3 months by
`latanoprost and tafluprost
`
`actual paper, however, has never been published. Clinical
`trial number Umin-CTR, UMIN000002017.
`
`Incidence of eyes
`showing increase
`of eyelash
`Length
`n
`%
`9
`30.0
`8
`26.7
`13
`43.3
`
`Amount
`n
`%
`5
`16.7
`9
`30.0
`16
`53.3
`
`Effect by Lat
`Effect by Taf
`No effect by
`both Lat and Taf
`Abbreviations: Lat, latanoprost; Taf, tafluprost.
`
`Incidence of eyes
`showing increase
`of pigmentation
`Eyelid
`Iris
`n
`%
`n
`1
`3.3
`2
`6
`20.0
`1
`23
`76.7
`27
`
`%
`6.7
`3.3
`90.0
`
`Lat, whereas increased eyelash amount was more frequently
`found in Taf. Since the patients involved in this study were
`already users of Lat for over 1 month, it was difficult to
`make a simple comparison between the two drugs in regard
`to the adverse events of newly appearing eyelid and iris pig-
`mentation or eyelash elongation. In this study, there was a
`tendency of more eyelid pigmentation with Taf than with Lat.
`According to past reports for eyelash length, eyelash amount,
`eyelid pigmentation, and iris pigmentation, the appearance
`rate was 0–25.8/0.38%, 26/46%, 1.5–6.0/1.08%–4%, and
`0–12.3/4.0% with Lat/Taf,7,13,14,16–21 respectively. Our results
`were nearly the same as those of the previous reports, except
`for iris and eyelid pigmentation. Our findings showed that
`eyelid pigmentation was greater with Taf than with Lat, yet
`with no significant difference. We must investigate further
`eyelid pigmentation induced by Taf.
`It should be noted that this study did include some limi-
`tations. The first limitation was that this was not a masked
`study, as both the subjects and the attending doctor knew
`which eye drop was being used. The second limitation was
`that since the baseline IOP of all subjects using Lat was low, it
`was difficult to find the switching efficacy of the eye drop.
`
`Conclusion
`The findings of this study show that Lat and Taf have
`equivalent safety and efficacy in Japanese NTG patients
`with low IOP.
`
`Acknowledgments
`The authors wish to thank Mr John Bush for reviewing
`this manuscript. The abstract of this paper was submitted
`at the ARVO Annual Meeting, May 1–5, 2011 as a poster
`presentation with interim findings. The poster’s abstract
`was published in “Poster Abstracts” in Investigative
`Ophthalmology and Visual Science Vol 52, Issue 14. The
`
`Disclosure
`The authors report no conflicts of interest in this work.
`
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