Evidence map›Paper›PMID 27457469›Full record

Trial reportAdvances in therapy2016

Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study.

Kazuhide Kawase, Jason L Vittitow, Robert N Weinreb, Makoto Araie, JUPITER Study Group

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Advances in therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01895972 (A Single-Arm, Multicenter, Open-Label Study Evaluating the Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024%, in Japanese Subjects With Open-Angle Glaucoma or Ocular Hypertension), which is not on this map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
7.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01895972 phase3completednot on this map

A Single-Arm, Multicenter, Open-Label Study Evaluating the Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024%, in Japanese Subjects With Open-Angle Glaucoma or Ocular Hypertension

TypeinterventionalSponsorBausch & Lomb IncorporatedRan2013 to 2015Enrolled130ConditionsGlaucoma, Ocular HypertensionArmsLatanoprostene bunod
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 78 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Different intraocular pressure-lowering effects of latanoprostene bunod across glaucoma subtypes: a 12-month real-world clinical study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Observational
  11. Article
  12. Review
  13. Review
  14. Review
  15. Newer advances in medical management of glaucoma.Indian journal of ophthalmology · 2022
    Review
  16. Article
  17. Nitric Oxide Interaction with the Eye.Vision (Basel, Switzerland) · 2021
    Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Kazuhide KawaseGifu University Hospital, Gifu, Japan. kawase-gif@umin.ac.jp.
Jason L VittitowClinical Affairs, Bausch + Lomb, Bridgewater, NJ, USA.
Robert N WeinrebDepartment of Ophthalmology and Shiley Eye Institute, Hamilton Glaucoma Center, University of California San Diego, La Jolla, CA, USA.
Makoto AraieKanto Central Hospital of The Mutual Aid Association of Public School Teachers, Tokyo, Japan.
JUPITER Study Group
Gifu University Hospital · JPBausch Health (United States) · USKanto Central Hospital · JPUniversity of California San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLatanoprostene bunod (LBN) is a novel nitric oxide (NO)-donating prostaglandin F2α 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).

methodsThis 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.

resultsOf 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).

conclusionOnce 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 registrationClinicalTrials.gov identifier, NCT01895972.

fundingBausch & Lomb, Inc. a division of Valeant Pharmaceuticals International Inc.

Indexed as

Conjunctival DiseasesGlaucoma, Open-AngleLong Term Adverse EffectsProstaglandins F, SyntheticAntihypertensive AgentsDinoprostDrug MonitoringFemaleHumansIntraocular PressureJapanMaleMiddle AgedOphthalmic SolutionsTonometry, OcularTreatment OutcomeAntihypertensive AgentsBOL 303259-XDinoprostOphthalmic SolutionsProstaglandins F, SyntheticIntraocular pressureNitric oxideOcular hypertensionOpen-angle glaucomaOphthalmologyProstaglandin

Identifiers

PMID27457469
PMCPMC5020123
OpenAlexW2499331021

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.