A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China

Launched by SANTEN PHARMACEUTICAL CO., LTD. · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new eye drop treatment called DE-117B for people with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The aim is to see how safe and effective these eye drops are when used daily for a week. Participants will first stop their current eye pressure-lowering medications to ensure accurate results. The trial will measure how the medicine behaves in the body and monitor any side effects.

To be eligible for this study, participants must be diagnosed with POAG or OHT in both eyes, have a certain level of vision, and meet specific eye measurements. They should also have high eye pressure at the start of the study. Unfortunately, some individuals may not qualify if they have serious eye conditions, recent eye surgeries, or are pregnant. Those who join the study can expect regular check-ups to monitor their eye health and the effects of the new treatment. Overall, this trial is a great opportunity for eligible individuals to explore a potential new option for managing their eye condition.

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ALL

Eligibility criteria

• 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.