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
|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)|
|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|
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
- 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.
- 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.
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
|United States, New Jersey|
|Bausch & Lomb Incorporated|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Jason L. Vittitow, PhD||Bausch & Lomb Incorporated|