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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01895972
First received: July 3, 2013
Last updated: August 21, 2014
Last verified: August 2014

July 3, 2013
August 21, 2014
July 2013
April 2015   (final data collection date for primary outcome measure)
  • 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 baseline) [ 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%.
Same as current
Complete list of historical versions of study NCT01895972 on ClinicalTrials.gov Archive Site
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Not Provided
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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
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
Drug: Latanoprostene bunod
Other Name: BOL-303259-X
Experimental: Latanoprostene Bunod
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Intervention: Drug: Latanoprostene bunod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
May 2015
April 2015   (final data collection date for primary outcome measure)

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).
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01895972
811
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Jason L. Vittitow, PhD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP