Phase 3
Completed N=130
Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
Source: ClinicalTrials.gov NCT01895972 ↗Enrolled (actual)
130
Serious AEs
3.9%
Results posted
Jun 2018
Primary outcomePrimary: Change From Baseline in Intraocular Pressure — -4.30; -4.57; -4.76; -4.79 mm Hg — p=<0.001
◆ Published Evidence
Established
79citations · ~8 / year
Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study.
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.
Linked Publications
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Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Intraocular Pressure |
-4.30; -4.57; -4.76; -4.79; -4.94; -4.94 | <0.001 sig |
| PRIMARY Clinical Safety |
76 | — |
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).
Data sourced from ClinicalTrials.gov (NCT01895972) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.