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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Bausch & Lomb Incorporated
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01895972
First received: July 3, 2013
Last updated: November 22, 2013
Last verified: November 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%.

  • IOP (Change from basline) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Systemic adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%.


Estimated 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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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 visual acuity (VA) 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 within 3 months prior to Visit 1 (Screening).
  • Subjects with a history of ocular laser surgery within the 3 months (90 days) prior to Visit 1 (Screening).
  • Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895972

Contacts
Contact: Yosuke Hagiwara +81-3-5763-3454 Yosuke.Hagiwara@bausch.com

Locations
United States, New Jersey
Bausch & Lomb Incorporated Recruiting
Madison, New Jersey, United States, 07940
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Quintus Ngumah, OD, PhD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01895972     History of Changes
Other Study ID Numbers: 811
Study First Received: July 3, 2013
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014