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NCT01895972: JUPITER

Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT

Completed Phase 3 Results posted Last updated 26 July 2018
What this trial tests

Phase 3 trial testing Latanoprostene bunod in Glaucoma in 130 participants. Completed in 14 April 2015.

Timeline
5 July 2013
Primary endpoint
2 April 2015
14 April 2015

Quick facts

Lead sponsorBausch & Lomb Incorporated
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment130
Start date5 July 2013
Primary completion2 April 2015
Estimated completion14 April 2015
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Bausch & Lomb Incorporated — full company profile →

Who can join

20 and older, any sex, with Glaucoma or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Intraocular Pressure Primary · Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52

Change from baseline in intraocular pressure (IOP) following treatment with latanoprostene bunod 0.024% (instilled QD in the evening) with IOP assessed every 4 weeks from Week 4 to Week 52.

Week 4
GroupValue95% CI
Latanoprostene Bunod-4.30± 2.746
Week 8
GroupValue95% CI
Latanoprostene Bunod-4.57± 2.610
Week 12
GroupValue95% CI
Latanoprostene Bunod-4.76± 2.846
Week 16
GroupValue95% CI
Latanoprostene Bunod-4.79± 2.742
Week 20
GroupValue95% CI
Latanoprostene Bunod-4.94± 2.707
Week 24
GroupValue95% CI
Latanoprostene Bunod-4.94± 2.877
Week 28
GroupValue95% CI
Latanoprostene Bunod-4.93± 2.703
Week 32
GroupValue95% CI
Latanoprostene Bunod-5.04± 2.789
Clinical Safety Primary · 1 year

Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with \>/=1 ocular AE Specifics of AEs are captured in the AE section.

GroupValue95% CI
Latanoprostene Bunod76

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Latanoprostene Bunod
Serious: 5/130 (4%)
Deaths:

Serious adverse events (6 terms)

ReactionSystemLatanoprostene Bunod
Stomach cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
vestibular neuronitisInfections and infestations
Car accidentInjury, poisoning and procedural complications
left tibia plateau fractureInjury, poisoning and procedural complications
Lung CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung ademocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Other adverse events (30 terms — click to expand)

ReactionSystemLatanoprostene Bunod
Conjunctival hyperemiaEye disorders
Growth of eyelashesEye disorders
Eye irritationEye disorders
Eye painEye disorders
Iris hyperpigmentationEye disorders
Blepheral pigmentationEye disorders
AsthenopiaEye disorders
BlepharitisEye disorders
Eye pruritusEye disorders
Punctate keratitisEye disorders
TrichiasisEye disorders
Conjunctival haemorrhageEye disorders
Abnormal sensation in the eyeEye disorders
CataractEye disorders
Conjunctivitis allergicEye disorders
Conjunctivits bacterialEye disorders
Corneal erosionEye disorders
Dry eyeEye disorders
Eczema eyelidsEye disorders
Eye dischargeEye disorders
Eyelid aedemaEye disorders
Eyelid pruritusEye disorders
Foreign body in eyeEye disorders
Foreign body sensation in eyesEye disorders
HordelolumEye disorders
Hypopigmentation of eyelidEye disorders
Keratitis herpeticEye disorders
Ocular discomfortEye disorders
Visual impairmentEye disorders
Vitreous floatersEye disorders

Most-reported serious reactions: Stomach cancer, vestibular neuronitis, Car accident, left tibia plateau fracture, Lung Cancer, Lung ademocarcinoma.

Data from ClinicalTrials.gov NCT01895972 adverse events section.

Sponsor's own description

The objective of this study is to demonstrate the clinical safety of latanoprostene bunod 0.024% once daily (QD) over a 1-year treatment period.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Systemic medication and intraocular pressure in a British population: the EPIC-Norfolk Eye Study.
    Khawaja AP, Chan MP, Broadway DC, Garway-Heath DF, et al · · 2014 · cited 60× · PMID 24702754 · DOI 10.1016/j.ophtha.2014.02.009
  2. Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study.
    Kawase K, Vittitow JL, Weinreb RN, Araie M, et al · · 2016 · cited 49× · PMID 27457469 · DOI 10.1007/s12325-016-0385-7
  3. Prostaglandin analogues and nitric oxide contribution in the treatment of ocular hypertension and glaucoma.
    Impagnatiello F, Bastia E, Almirante N, Brambilla S, et al · · 2019 · cited 41× · PMID 29669171 · DOI 10.1111/bph.14328
  4. Critical evaluation of latanoprostene bunod in the treatment of glaucoma.
    Garcia GA, Ngai P, Mosaed S, Lin KY. · · 2016 · cited 30× · PMID 27799730 · DOI 10.2147/opth.s103985
  5. Drug discovery in ophthalmology: past success, present challenges, and future opportunities.
    Gower NJD, Barry RJ, Edmunds MR, Titcomb LC, et al · · 2016 · cited 30× · PMID 26774505 · DOI 10.1186/s12886-016-0188-2
  6. Latanoprostene bunod ophthalmic solution 0.024%: a new treatment option for open-angle glaucoma and ocular hypertension.
    Fingeret M, Gaddie IB, Bloomenstein M. · · 2019 · cited 13× · PMID 30614563 · DOI 10.1111/cxo.12853

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Other recruiting trials for Glaucoma

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