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A Study Evaluating the Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024%, in Japanese Subjects With Open-Angle Glaucoma or Ocular Hypertension (JUPITER)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Bausch & Lomb Incorporated.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01895972
First Posted: July 11, 2013
Last Update Posted: August 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
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.

Condition Intervention Phase
Glaucoma Ocular Hypertension Drug: Latanoprostene bunod Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: 1 year ]
    Intraocular pressure (IOP) following 1-year of treatment with latanoprostene bunod 0.024% administered once daily to the eye.

  • Incidence of ocular adverse events (AEs) [ Time Frame: 1 year ]
    Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%.

  • IOP (Change from baseline) [ Time Frame: 1 year ]
    Change from baseline in intraocular pressure (IOP) over a 1-year treatment period of latanoprostene bunod 0.024% administered once daily to the eye.

  • Systemic AE's [ Time Frame: 1 year ]
    Systemic adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%.


Enrollment: 130
Study Start Date: July 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Latanoprostene Bunod
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Drug: Latanoprostene bunod
Other Name: BOL-303259-X

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895972


Locations
United States, New Jersey
Bausch & Lomb Incorporated
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Jason L. Vittitow, PhD Bausch & Lomb Incorporated
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01895972     History of Changes
Other Study ID Numbers: 811
First Submitted: July 3, 2013
First Posted: July 11, 2013
Last Update Posted: August 22, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions


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