Long-Term Safety of Latanoprostene Bunod Ophthalmic Solut... | NCT01895972

NCT01895972

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Label	Type	Description	Intervention Names
Latanoprostene Bunod	Experimental	Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.	Drug: Latanoprostene bunod

Name	Type	Description	Arm Group Labels	Other Names
Latanoprostene bunod	Drug		Latanoprostene Bunod	BOL-303259-X

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Eligibility Module

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).

Name	Affiliation	Role
Jason L. Vittitow, PhD	Bausch & Lomb Incorporated	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Bausch & Lomb Incorporated		Bridgewater	New Jersey	08807	United States

PubMed Identifier	Type	Citation	Retractions
27457469	Result	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.

ID	Title	Description
FG000	Latanoprostene Bunod	Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period. Latanoprostene bunod

Baseline Characteristics Module

ID	Title	Description
BG000	Latanoprostene Bunod	Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period. Latanoprostene bunod

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Safety population

Posted

Mean

Standard Deviation

mm Hg

Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52

ID	Title	Description
OG000	Latanoprostene Bunod	Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period. Latanoprostene bunod

Units	Counts
Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Latanoprostene Bunod	Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period. Latanoprostene bunod

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Stomach cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension