Glaucoma, Ocular Hypertension
Conditions
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.
Interventions
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure | Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52 | 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. |
| Clinical Safety | 1 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Latanoprostene Bunod Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Latanoprostene bunod | 130 |
| Total | 130 |
Baseline characteristics
| Characteristic | Latanoprostene Bunod |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 10.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Japanese | 130 Participants |
| Region of Enrollment Japan | 130 Participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 76 / 130 |
| serious Total, serious adverse events | 5 / 130 |
Outcome results
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.
Time frame: Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 4 | -4.30 mm Hg | Standard Deviation 2.746 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 8 | -4.57 mm Hg | Standard Deviation 2.61 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 12 | -4.76 mm Hg | Standard Deviation 2.846 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 16 | -4.79 mm Hg | Standard Deviation 2.742 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 20 | -4.94 mm Hg | Standard Deviation 2.707 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 24 | -4.94 mm Hg | Standard Deviation 2.877 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 28 | -4.93 mm Hg | Standard Deviation 2.703 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 32 | -5.04 mm Hg | Standard Deviation 2.789 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 36 | -5.32 mm Hg | Standard Deviation 2.778 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 40 | -5.25 mm Hg | Standard Deviation 2.629 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 44 | -5.12 mm Hg | Standard Deviation 2.862 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 48 | -5.12 mm Hg | Standard Deviation 2.741 |
| Latanoprostene Bunod | Change From Baseline in Intraocular Pressure | Week 52 | -5.25 mm Hg | Standard Deviation 2.633 |
Comparison: comparison vs. baselinep-value: <0.001t-test, 2 sided
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.
Time frame: 1 year
Population: Safety Population (Study Eye)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latanoprostene Bunod | Clinical Safety | 76 Participants |