Status:
COMPLETED
Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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
- 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
- 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).
Key Trial Info
Start Date :
July 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2015
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01895972
Start Date
July 5 2013
End Date
April 14 2015
Last Update
July 26 2018
Active Locations (1)
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1
Bausch & Lomb Incorporated
Bridgewater, New Jersey, United States, 08807