Clinical trial NCT01895972: Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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).

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure
timeFrame: Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52
measure: Clinical Safety
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Bausch & Lomb Incorporated
state: New Jersey
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jason L. Vittitow, PhD
role: STUDY_DIRECTOR
References:
citation: 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: 10.1007/s12325-016-0385-7. Epub 2016 Jul 25.