Status:
RECRUITING
A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
Lead Sponsor:
Santen Pharmaceutical Co., Ltd.
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 (P...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT06666855
Start Date
November 28 2024
End Date
March 31 2026
Last Update
February 28 2025
Active Locations (25)
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1
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
2
Beijing Hospital
Beijing, China
3
Beijing Tongren Hospital, Capital Medical University
Beijing, China
4
Peking University Third Hospital
Beijing, China