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

Prior treatment

• Anterior segment or intraocular surgery (other than glaucoma) within 90 days prior to start of washout phase.
• 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.
• Current participation in another clinical study, or participation and treatment with study medication within 90 days before the start of the washout phase.

Other illness

• 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).
• 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).

Other

• Pseudophakic eye, aphakic eye.
• 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.

• 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.