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

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ClinicalTrials.gov Identifier: NCT01895972
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Latanoprostene bunod Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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
Actual Study Start Date : July 5, 2013
Actual Primary Completion Date : April 2, 2015
Actual Study Completion Date : April 14, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Reduction From Baseline in Intraocular Pressure [ Time Frame: 1 year ]
    Reductions 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.

  2. 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 proportion of subjects with >/=1 ocular AE Specifics of AEs are captured in the AE section.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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).

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

Publications of Results:
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01895972     History of Changes
Other Study ID Numbers: 811
First Posted: July 11, 2013    Key Record Dates
Results First Posted: June 5, 2018
Last Update Posted: June 5, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions