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

Inclusion Criteria:

• Patients diagnosed with primary open angle glaucoma or ocular hypertension in botheyes.

• 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 inboth eyes at all measurement time points.

Exclusion Criteria:

• Consider visual field disorder at risk for progression during the study based on thecurrent clinical examination result.

• Severe visual field disorder (e.g., mean deviation lower than -12 dB, as assessed byHumphrey field analyzer).

• Any corneal abnormality or other condition potentially interfering with reliableapplanation tonometry.

• History of iritis or uveitis.

• Presence of any active external ocular disease, inflammation, or infection of theeye or eyelids.

• History of macular oedema, retinal detachment, or diabetic retinopathy, or currentretinal 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 priorto 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 eyedrops).

• Intended use of prohibited concomitant medications or therapies during the study.

• Required use of contact lenses from 1 week before treatment phase initiation andduring the study.

• Pseudophakic eye, aphakic eye.

• Current participation in another clinical study, or participation and treatment withstudy medication within 90 days before the start of the washout phase.

• Females who are pregnant, nursing, or potentially pregnant (e.g., positive pregnancytest), planning a pregnancy during the study, or unable to use appropriatecontraception during the study.