Trial Outcomes & Findings for Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT (NCT NCT01895972)
NCT ID: NCT01895972
Last Updated: 2018-07-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
Latanoprostene Bunod
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Latanoprostene bunod
|
|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
COMPLETED
|
121
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
Baseline characteristics by cohort
| Measure |
Latanoprostene Bunod
n=130 Participants
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Latanoprostene bunod
|
|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 10.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
130 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
130 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
130 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52Population: Safety population
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.
Outcome measures
| Measure |
Latanoprostene Bunod
n=130 Participants
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Latanoprostene bunod
|
|---|---|
|
Change From Baseline in Intraocular Pressure
Week 4
|
-4.30 mm Hg
Standard Deviation 2.746
|
|
Change From Baseline in Intraocular Pressure
Week 8
|
-4.57 mm Hg
Standard Deviation 2.610
|
|
Change From Baseline in Intraocular Pressure
Week 12
|
-4.76 mm Hg
Standard Deviation 2.846
|
|
Change From Baseline in Intraocular Pressure
Week 16
|
-4.79 mm Hg
Standard Deviation 2.742
|
|
Change From Baseline in Intraocular Pressure
Week 20
|
-4.94 mm Hg
Standard Deviation 2.707
|
|
Change From Baseline in Intraocular Pressure
Week 24
|
-4.94 mm Hg
Standard Deviation 2.877
|
|
Change From Baseline in Intraocular Pressure
Week 28
|
-4.93 mm Hg
Standard Deviation 2.703
|
|
Change From Baseline in Intraocular Pressure
Week 32
|
-5.04 mm Hg
Standard Deviation 2.789
|
|
Change From Baseline in Intraocular Pressure
Week 36
|
-5.32 mm Hg
Standard Deviation 2.778
|
|
Change From Baseline in Intraocular Pressure
Week 40
|
-5.25 mm Hg
Standard Deviation 2.629
|
|
Change From Baseline in Intraocular Pressure
Week 44
|
-5.12 mm Hg
Standard Deviation 2.862
|
|
Change From Baseline in Intraocular Pressure
Week 48
|
-5.12 mm Hg
Standard Deviation 2.741
|
|
Change From Baseline in Intraocular Pressure
Week 52
|
-5.25 mm Hg
Standard Deviation 2.633
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Safety Population (Study Eye)
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.
Outcome measures
| Measure |
Latanoprostene Bunod
n=130 Participants
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Latanoprostene bunod
|
|---|---|
|
Clinical Safety
|
76 Participants
|
Adverse Events
Latanoprostene Bunod
Serious events: 5 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Latanoprostene Bunod
n=130 participants at risk
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Latanoprostene bunod
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stomach cancer
|
0.77%
1/130 • 1 year
|
|
Infections and infestations
vestibular neuronitis
|
0.77%
1/130 • 1 year
|
|
Injury, poisoning and procedural complications
Car accident
|
0.77%
1/130 • 1 year
|
|
Injury, poisoning and procedural complications
left tibia plateau fracture
|
0.77%
1/130 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.77%
1/130 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung ademocarcinoma
|
0.77%
1/130 • 1 year
|
Other adverse events
| Measure |
Latanoprostene Bunod
n=130 participants at risk
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Latanoprostene bunod
|
|---|---|
|
Eye disorders
Abnormal sensation in the eye
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Asthenopia
|
2.3%
3/130 • 1 year
|
|
Eye disorders
Blepheral pigmentation
|
3.1%
4/130 • 1 year
|
|
Eye disorders
Blepharitis
|
2.3%
3/130 • 1 year
|
|
Eye disorders
Cataract
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Conjunctival haemorrhage
|
1.5%
2/130 • 1 year
|
|
Eye disorders
Conjunctival hyperemia
|
17.7%
23/130 • 1 year
|
|
Eye disorders
Conjunctivitis allergic
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Conjunctivits bacterial
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Corneal erosion
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Dry eye
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Eczema eyelids
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Eye discharge
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Eye irritation
|
11.5%
15/130 • 1 year
|
|
Eye disorders
Eye pain
|
10.0%
13/130 • 1 year
|
|
Eye disorders
Eye pruritus
|
2.3%
3/130 • 1 year
|
|
Eye disorders
Eyelid aedema
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Eyelid pruritus
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Foreign body in eye
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Foreign body sensation in eyes
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Growth of eyelashes
|
16.2%
21/130 • 1 year
|
|
Eye disorders
Hordelolum
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Hypopigmentation of eyelid
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Iris hyperpigmentation
|
3.8%
5/130 • 1 year
|
|
Eye disorders
Keratitis herpetic
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Ocular discomfort
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Punctate keratitis
|
2.3%
3/130 • 1 year
|
|
Eye disorders
Trichiasis
|
2.3%
3/130 • 1 year
|
|
Eye disorders
Visual impairment
|
0.77%
1/130 • 1 year
|
|
Eye disorders
Vitreous floaters
|
0.77%
1/130 • 1 year
|
Additional Information
H. DeCory, Director Medical Affairs
Bausch + Lomb, a division of Valeant Pharmaceuticals
Phone: 585 732-3284
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place