PMID- 27457469
OWN - NLM
STAT- MEDLINE
DCOM- 20170831
LR  - 20231111
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 33
IP  - 9
DP  - 2016 Sep
TI  - Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects 
      with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study.
PG  - 1612-27
LID - 10.1007/s12325-016-0385-7 [doi]
AB  - INTRODUCTION: Latanoprostene bunod (LBN) is a novel nitric oxide (NO)-donating 
      prostaglandin F2alpha analog. We evaluated the long-term safety and intraocular 
      pressure (IOP)-lowering efficacy of LBN ophthalmic solution 0.024% over 1 year in 
      Japanese subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). 
      METHODS: This was a single-arm, multicenter, open-label, clinical study. Subjects 
      aged 20 years and older with a diagnosis of OAG or OHT instilled 1 drop of LBN 
      ophthalmic solution 0.024% in the affected eye(s) once daily in the evening for 
      52 weeks and were evaluated every 4 weeks. Safety assessments included vital 
      signs, comprehensive ophthalmic exams, and treatment-emergent adverse events 
      (AEs). Absolute and percent reductions from baseline in IOP were also determined. 
      RESULTS: Of 130 subjects enrolled, 121 (93.1%) completed the study. Mean age was 
      62.5 years, and mean (standard deviation) baseline IOP was 19.6 (2.9) and 18.7 
      (2.6) mmHg in study eyes and treated fellow eyes, respectively. Overall, 76/130 
      (58.5%) and 78/126 (61.9%) subjects experienced >/=1 AEs in study eyes and treated 
      fellow eyes, respectively. In both study eyes and treated fellow eyes, the most 
      common AEs were conjunctival hyperemia, growth of eyelashes, eye irritation, and 
      eye pain. At 52 weeks, 9% of treated eyes had an increase in iris pigmentation 
      compared with baseline based on iris photographs. No safety concerns emerged 
      based on vital signs or other ocular assessments. Mean reductions from baseline 
      in IOP of 22.0% and 19.5% were achieved by week 4 in study and treated fellow 
      eyes, respectively. These reductions were maintained through week 52 (P < 0.001 
      vs. baseline at all visits). CONCLUSION: Once daily LBN ophthalmic solution 
      0.024% was safe and well-tolerated in Japanese subjects with OAG or OHT when used 
      for up to 1 year. Long-term treatment with LBN ophthalmic solution 0.024% 
      provided significant and sustained IOP reduction. TRIAL REGISTRATION: 
      ClinicalTrials.gov identifier, NCT01895972. FUNDING: Bausch & Lomb, Inc. a 
      division of Valeant Pharmaceuticals International Inc.
FAU - Kawase, Kazuhide
AU  - Kawase K
AD  - Gifu University Hospital, Gifu, Japan. kawase-gif@umin.ac.jp.
FAU - Vittitow, Jason L
AU  - Vittitow JL
AD  - Clinical Affairs, Bausch + Lomb, Bridgewater, NJ, USA.
FAU - Weinreb, Robert N
AU  - Weinreb RN
AD  - Department of Ophthalmology and Shiley Eye Institute, Hamilton Glaucoma Center, 
      University of California San Diego, La Jolla, CA, USA.
FAU - Araie, Makoto
AU  - Araie M
AD  - Kanto Central Hospital of The Mutual Aid Association of Public School Teachers, 
      Tokyo, Japan.
CN  - JUPITER Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01895972
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160725
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Antihypertensive Agents)
RN  - 0 (BOL 303259-X)
RN  - 0 (Ophthalmic Solutions)
RN  - 0 (Prostaglandins F, Synthetic)
RN  - B7IN85G1HY (Dinoprost)
MH  - Antihypertensive Agents/administration & dosage/adverse effects
MH  - *Conjunctival Diseases/chemically induced/diagnosis/prevention & control
MH  - Dinoprost
MH  - Drug Monitoring/methods
MH  - Female
MH  - *Glaucoma, Open-Angle/diagnosis/drug therapy
MH  - Humans
MH  - Intraocular Pressure/*drug effects
MH  - Japan
MH  - *Long Term Adverse Effects/chemically induced/diagnosis/prevention & control
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions/administration & dosage/adverse effects
MH  - *Prostaglandins F, Synthetic/administration & dosage/adverse effects
MH  - Tonometry, Ocular/methods
MH  - Treatment Outcome
PMC - PMC5020123
OTO - NOTNLM
OT  - Intraocular pressure
OT  - Nitric oxide
OT  - Ocular hypertension
OT  - Open-angle glaucoma
OT  - Ophthalmology
OT  - Prostaglandin
FIR - Hoshiai, Shigeru
IR  - Hoshiai S
FIR - Hashida, Setsuko
IR  - Hashida S
FIR - Iwasaki, Miki
IR  - Iwasaki M
FIR - Kano, Kiyoshi
IR  - Kano K
FIR - Kawase, Kazuhide
IR  - Kawase K
FIR - Kato, Takuji
IR  - Kato T
FIR - Kuwayama, Yasuaki
IR  - Kuwayama Y
FIR - Muramatsu, Tomoyuki
IR  - Muramatsu T
FIR - Mitsuhashi, Masatada
IR  - Mitsuhashi M
FIR - Matsuzaki, Sakae
IR  - Matsuzaki S
FIR - Nakajima, Toru
IR  - Nakajima T
FIR - Sato, Isao
IR  - Sato I
FIR - Yoshimura, Yuzuru
IR  - Yoshimura Y
EDAT- 2016/07/28 06:00
MHDA- 2017/09/01 06:00
PMCR- 2016/07/25
CRDT- 2016/07/27 06:00
PHST- 2016/06/14 00:00 [received]
PHST- 2016/07/27 06:00 [entrez]
PHST- 2016/07/28 06:00 [pubmed]
PHST- 2017/09/01 06:00 [medline]
PHST- 2016/07/25 00:00 [pmc-release]
AID - 10.1007/s12325-016-0385-7 [pii]
AID - 385 [pii]
AID - 10.1007/s12325-016-0385-7 [doi]
PST - ppublish
SO  - Adv Ther. 2016 Sep;33(9):1612-27. doi: 10.1007/s12325-016-0385-7. Epub 2016 Jul 
      25.