PMID- 29873009
OWN - NLM
STAT- MEDLINE
DCOM- 20190903
LR  - 20210921
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 35
IP  - 6
DP  - 2018 Jun
TI  - Multicenter, Randomized, Controlled Study Comparing Tafluprost/Timolol Fixed 
      Combination with Latanoprost/Timolol Fixed Combination in Primary Open-Angle 
      Glaucoma and Ocular Hypertension.
PG  - 796-808
LID - 10.1007/s12325-018-0718-9 [doi]
AB  - INTRODUCTION: This was the first exploratory randomized controlled study to 
      compare the efficacy and safety of a preserved tafluprost/timolol fixed 
      combination (TAF/TIM) with a preserved latanoprost/timolol fixed combination 
      (LAT/TIM). METHODS: This prospective, randomized, open-label study was conducted 
      in Japanese patients with primary open-angle glaucoma, including normal-tension 
      glaucoma or ocular hypertension. Following a 4-week LAT/TIM run-in period, 
      eligible patients entered a 12-week treatment period, during which they received 
      either LAT/TIM or TAF/TIM. The efficacy endpoint was the change in intraocular 
      pressure (IOP) from baseline to week 12 and the safety endpoints included the 
      changes from baseline to week 12 in superficial punctate keratopathy (SPK) score, 
      tear breakup time (TBUT), and hyperemia score, as well as adverse events (AEs). 
      At week 6, ocular symptoms were evaluated using a questionnaire. RESULTS: In 
      total, 131 patients provided informed consent. Of these, 115 completed the run-in 
      period and were assigned to receive TAF/TIM (n = 60) or LAT/TIM (n = 55). At week 
      12, there were no significant differences between the TAF/TIM and LAT/TIM groups 
      in the change from baseline in trough IOP and IOP at 4-6 h after instillation. 
      There were no significant differences between the two groups in the change from 
      baseline to week 12 in SPK score, TBUT, and hyperemia score. However, only in the 
      TAF/TIM group, the total SPK score and the inferior cornea SPK score were 
      significantly lower at week 12 compared with baseline. Eye irritation and eye 
      pain were significantly decreased in the TAF/TIM group compared with the LAT/TIM 
      group. Two treatment-related AEs were reported in the TAF/TIM group (3.3%) and 
      none in the LAT/TIM group, while no serious AEs were reported in either group. 
      CONCLUSION: TAF/TIM is as effective as LAT/TIM in terms of IOP-reducing effect, 
      with fewer ocular symptoms. TAF/TIM was associated with a significant improvement 
      in SPK scores. TRIAL REGISTRATION: UMIN Clinical Trials Registry Identifier, 
      UMIN000023862. FUNDING: Santen Pharmaceutical Co., Ltd., Osaka, Japan.
FAU - Suzuki, Katsuyoshi
AU  - Suzuki K
AD  - Suzuki Eye Clinic, Yamaguchi, Japan. suzuki_eye@grace.ocn.ne.jp.
FAU - Otsuka, Naomi
AU  - Otsuka N
AD  - Santen Pharmaceutical Co., Ltd., Osaka, Japan.
FAU - Hizaki, Hiroko
AU  - Hizaki H
AD  - Santen Pharmaceutical Co., Ltd., Osaka, Japan.
FAU - Hashimoto, Masayo
AU  - Hashimoto M
AD  - Santen Pharmaceutical Co., Ltd., Osaka, Japan.
FAU - Kuwayama, Yasuaki
AU  - Kuwayama Y
AD  - Fukushima Eye Clinic, Osaka, Japan.
CN  - Tafluprost/Timolol Versus Latanoprost/Timolol (TTVLT) Study Group
LA  - eng
SI  - UMIN-CTR/UMIN000023862
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180605
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Prostaglandins F)
RN  - 0 (Prostaglandins F, Synthetic)
RN  - 6Z5B6HVF6O (Latanoprost)
RN  - 817W3C6175 (Timolol)
EIN - Adv Ther. 2019 Feb;36(2):492-494. PMID: 30617814
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antihypertensive Agents/*therapeutic use
MH  - Drug Combinations
MH  - Female
MH  - Glaucoma, Open-Angle/*drug therapy
MH  - Humans
MH  - Intraocular Pressure/drug effects
MH  - Japan
MH  - Latanoprost/*therapeutic use
MH  - Low Tension Glaucoma/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Ocular Hypertension/*drug therapy
MH  - Prospective Studies
MH  - Prostaglandins F/*therapeutic use
MH  - Prostaglandins F, Synthetic/therapeutic use
MH  - Timolol/adverse effects/*therapeutic use
MH  - Tonometry, Ocular
MH  - Young Adult
OTO - NOTNLM
OT  - *Beta-blocker
OT  - *Efficacy
OT  - *Intraocular pressure
OT  - *Latanoprost
OT  - *Ocular hypertension
OT  - *Ophthalmology
OT  - *Primary open-angle glaucoma
OT  - *Prostaglandin
OT  - *Safety
OT  - *Tafluprost
EDAT- 2018/06/07 06:00
MHDA- 2019/09/04 06:00
CRDT- 2018/06/07 06:00
PHST- 2018/04/03 00:00 [received]
PHST- 2018/06/07 06:00 [pubmed]
PHST- 2019/09/04 06:00 [medline]
PHST- 2018/06/07 06:00 [entrez]
AID - 10.1007/s12325-018-0718-9 [pii]
AID - 10.1007/s12325-018-0718-9 [doi]
PST - ppublish
SO  - Adv Ther. 2018 Jun;35(6):796-808. doi: 10.1007/s12325-018-0718-9. Epub 2018 Jun 
      5.