search
Back to results

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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Latanoprostene bunod
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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).

Sites / Locations

  • Bausch & Lomb Incorporated

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Latanoprostene Bunod

Arm Description

Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2013
Last Updated
June 28, 2018
Sponsor
Bausch & Lomb Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT01895972
Brief Title
Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
Acronym
JUPITER
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 5, 2013 (Actual)
Primary Completion Date
April 2, 2015 (Actual)
Study Completion Date
April 14, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Latanoprostene Bunod
Arm Type
Experimental
Arm Description
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Intervention Type
Drug
Intervention Name(s)
Latanoprostene bunod
Other Intervention Name(s)
BOL-303259-X
Primary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure
Description
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.
Time Frame
Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52
Title
Clinical Safety
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason L. Vittitow, PhD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27457469
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs