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

Glaucoma Clinical Trial

— JUPITER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895972
• Other study ID #: 811
• Status: Completed
• Phase: Phase 3
• Start date: July 5, 2013
• Est. completion date: April 14, 2015

Study information

• Verified date: June 2018
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 14, 2015
• Est. primary completion date: April 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Latanoprostene bunod

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kawase K, Vittitow JL, Weinreb RN, Araie M; JUPITER Study Group. Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study. Adv Ther. 2016 Sep;33(9):1612-27. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Intraocular Pressure	Change 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.	Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52
Primary	Clinical Safety	Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with >/=1 ocular AE Specifics of AEs are captured in the AE section.	1 year