Ocular Hypertension, Open Angle Glaucoma
Conditions
Brief summary
This is a Phase III Study that includes a single arm, open-label, multi-dose PK study cohort and a randomized, evaluator-masked, active drug-control multicenter study. Subjects diagnosed with POAG (Primary Open Angle Glaucoma) or OHT (Ocular Hypertension) who meet eligibility criteria will washout of their current IOP lowering medication(s), if any. The study will investigate plasma pharmacokinetics of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension. It will investigate the safety of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension. There will be a bridging cohort and extension follow-up phase
Interventions
DRUGDE-117B Eye Drops
Investigational Product: 0.002% DE-117B Eye Drops
DRUGLatanoprost
Active Control: 0.005% Latanoprost Eye Drops
Sponsors
Santen Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with primary open angle glaucoma or ocular hypertension in both eyes. * Corrected visual acuity ≥0.2 in both eyes. * Anterior chamber angle grade ≥2 (Shaffer scale) in both eyes. * Central corneal thickness ≥480 μm to ≤600 μm in both eyes. * At completion of the washout phase, IOP ≥22 mmHg in at least one eye and ≤34 mmHg in both eyes at all measurement time points.
Exclusion criteria
* Consider visual field disorder at risk for progression during the study based on the current clinical examination result. * Severe visual field disorder (e.g., mean deviation lower than -12 dB, as assessed by Humphrey field analyzer). * Any corneal abnormality or other condition potentially interfering with reliable applanation tonometry. * History of iritis or uveitis. * Presence of any active external ocular disease, inflammation, or infection of the eye or eyelids. * History of macular oedema, retinal detachment, or diabetic retinopathy, or current retinal disease at risk for progression during the study. * History of refractive keratotomy. * History of invasive surgery for glaucoma (including laser therapy). * Anterior segment or intraocular surgery (other than glaucoma) within 90 days prior to start of washout phase. * History of severe eye injury. * History of allergy to agents that were to be used during the study (e.g., benzalkonium chloride, instillation anesthetics, fluorescein, latanoprost eye drops). * Intended use of prohibited concomitant medications or therapies during the study. * Required use of contact lenses from 1 week before treatment phase initiation and during the study. * Pseudophakic eye, aphakic eye. * Current participation in another clinical study, or participation and treatment with study medication within 90 days before the start of the washout phase. * Females who are pregnant, nursing, or potentially pregnant (e.g., positive pregnancy test), planning a pregnancy during the study, or unable to use appropriate contraception during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) at Week 4 | Week 4 | Change from Baseline in Mean Diurnal IOP at Week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Intraocular Pressure (IOP) | Week 4 | Percent Change from Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 4 |
| Change and Percent Change in Intraocular Pressure (IOP) | Post baseline Visits except Week 4 | Change and Percent Change from Baseline in Mean Diurnal IOP at each post baseline visit except week 4. |
| Change and Percent Change from baseline in Intraocular Pressure (IOP) | Assessment time point at each post baseline visit. | Change and Percent Change from baseline in IOP at each IOP assessment time point at each post baseline visit. |
| Percentage of Responders | Each Post Baseline Visit. | Percentage of Responders (percent reduction from baseline in Mean Diurnal IOP: ≥20%, ≥25%, ≥30%) at each post baseline visit. |
Countries
China
Outcome results
None listed