GlaucomaPhase 3JUPITERNCT01895972

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

A Phase 3 study testing Latanoprostene bunod in people with Glaucoma and Ocular Hypertension, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: Latanoprostene bunod
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteUnited States
Study dates: 5 Jul 2013to 14 Apr 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma [NTG],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes.
Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day 0[after washout for the subjects already on treatment]): mean/median IOP ≥15 mmHg and ≤36 mmHg at 10 AM in at least 1 eye; and IOP ≤36 mmHg in both eyes.
Subjects with a corrected Decimal visual acuity (VA) or a Best-Corrected Decimal Visual Acuity (BCVA) of 0.5 or better in both eyes.

Who cannot join

Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and during study visits.
Subjects who are unable to discontinue other eye drop medications such as artificial tears for 15 minutes prior to and 15 minutes after instillation of study drug.
Subjects with a central corneal thickness greater than 600 μm in either eye.
Subjects with any condition that prevents reliable applanation tonometry in either eye.
Subjects with advanced glaucoma with a mean deviation (MD) < -12 dB, a history of split fixation, or a field loss threatening fixation in either eye.
Subjects with any condition that prevents clear visualization of the fundus.

Show all 15Show fewer

Subjects who are monocular (fellow eye is absent).
Subjects with aphakia in either eye.
Subjects with an active corneal disease in either eye.
Subjects with severe dry eye in either eye.
Subjects with a history/diagnosis of a clinically significant or progressive retinal disease in either eye.
Subjects with very narrow angles and subjects with angle closure congenital, or secondary glaucoma, and subjects with history of angle closure in either eye.
Subjects with any intraocular infection or inflammation in either eye within 3 months prior to Visit 1 (Screening).
Subjects with a history of ocular laser surgery in either eye within the 3 months (90 days) prior to Visit 1 (Screening).
Subjects with a history of incisional ocular surgery or severe trauma in either eye within 3 months prior to Visit 1 (Screening).

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb Incorporated
Bridgewater, New Jersey, 08807

Other trials in United States

About this study

Official title: 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

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.

Conditions: Glaucoma, Ocular Hypertension
Being tested: Latanoprostene bunod
Medical subject headings: Glaucoma, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Latanoprostene bunodDrug
Also called BOL-303259-X

Study groups in NCT01895972
Study group	Role	What they receive
Latanoprostene Bunod	Experimental	Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period. Receives: Drug: Latanoprostene bunod

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Intraocular Pressure
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.
Measured: Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52
Clinical Safety
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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 201314 Apr 2015

First posted11 Jul 2013 (estimated)
Study start5 Jul 2013
Primary completion2 Apr 2015
Study completion14 Apr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01895972
Sponsor's protocol ID: 811
Acronym: JUPITER
Status last verified: Jun 2018
First submitted: 3 Jul 2013
Last updated: 26 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kawase K, Vittitow JL, Weinreb RN, Araie M; JUPITER Study Group. Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study. Adv Ther. 2016 Sep;33(9):1612-27. doi: 10.1007/s12325-016-0385-7. Epub 2016 Jul 25.
PubMed 27457469

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01895972
Acronym / sponsor ID: JUPITER / 811
Conditions: Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 5 Jul 2013 (actual)
Primary completion: 2 Apr 2015 (actual)
Study completion: 14 Apr 2015 (actual)
First posted: 11 Jul 2013 (estimated)
Results: Posted 6 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Latanoprostene Bunod	Experimental	Drug: Latanoprostene bunodLatanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma [NTG],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes.
Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day 0[after washout for the subjects already on treatment]): mean/median IOP ≥15 mmHg and ≤36 mmHg at 10 AM in at least 1 eye; and IOP ≤36 mmHg in both eyes.
Subjects with a corrected Decimal visual acuity (VA) or a Best-Corrected Decimal Visual Acuity (BCVA) of 0.5 or better in both eyes.

Key exclusion criteria (15 listed)

Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and during study visits.
Subjects who are unable to discontinue other eye drop medications such as artificial tears for 15 minutes prior to and 15 minutes after instillation of study drug.
Subjects with a central corneal thickness greater than 600 μm in either eye.
Subjects with any condition that prevents reliable applanation tonometry in either eye.
Subjects with advanced glaucoma with a mean deviation (MD) < -12 dB, a history of split fixation, or a field loss threatening fixation in either eye.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Latanoprostene bunodAlso: BOL-303259-X	Drug	Latanoprostene Bunod

Primary outcome

Change From Baseline in Intraocular Pressure
Time frame: 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.
Clinical Safety
Time frame: 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.

Results and safety

Results posted to the registry on 6 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Latanoprostene Bunod	130	121

Primary outcome: Change From Baseline in Intraocular Pressure

Time frame: Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52. Mean (Standard Deviation). Unit: mm Hg

Measure	Latanoprostene Bunod n = 130
Week 4	-4.30 (2.746)
Week 8	-4.57 (2.610)
Week 12	-4.76 (2.846)
Week 16	-4.79 (2.742)
Week 20	-4.94 (2.707)
Week 24	-4.94 (2.877)
Week 28	-4.93 (2.703)
Week 32	-5.04 (2.789)

Latanoprostene Bunod: p <0.001, t-test, 2 sided

Population analysed: Safety population

Primary outcome: Clinical Safety

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Latanoprostene Bunod n = 130
Value	76

Population analysed: Safety Population (Study Eye)

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Latanoprostene Bunod	5 of 130 (3.8%)	76 of 130 (58.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27457469Kawase K, Vittitow JL, Weinreb RN, Araie M; JUPITER Study Group. Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study. Adv Ther. 2016 Sep;33(9):1612-27. doi: 10.1007/s12325-016-0385-7. Epub 2016 Jul 25.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason L. Vittitow, PhD study director

Bausch & Lomb Incorporated

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Latanoprostene bunod in people with Glaucoma and Ocular Hypertension, run by Bausch & Lomb Incorporated at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Intraocular Pressure (time frame: Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01895972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.