AL-54478 Proof of Concept Study

The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular hypertension.

Inclusion Criteria:

• Patients diagnosed with either OAG or OHT.
• Patients who are able to comply with the scheduled visits.
• Patients who have had a physical exam within 6 months of the Screening Visit.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Females of childbearing potential who meet any 1 of the following conditions: a) Currently pregnant; b) Positive urine pregnancy test; c)Intend to become pregnant; d) Breast feeding; e) Not using highly effective birth control measures.
• Patients with extreme narrow angle with complete or partial closure.
• Patients with a cup to disc ratio more than 0.8.
• Patients with a severe central visual field loss in either eye.
• Patients with chronic or recurrent inflammatory eye disease or acute ocular infection or inflammation.
• Patients who have had ocular trauma within the past 6 months or have had intraocular surgery within the past 6 months or have had ocular laser surgery within the past 3 months.
• Patients with best-correct visual acuity less than 20/80.
• Patients who have had ocular infection or inflammation within the past 3 months.
• Patients who have clinically relevant progressive retinal disease.
• Patients who have severe illness or conditions.
• Patients who have hypersensitivity to a prostaglandin analogu.e
• Patients who are unable to safely discontinue all IOP-lowering medications during washout.
• Patients who are currently on therapy with another investigational agent within 30 days prior to the Screening Visit.
• Other protocol-defined exclusion criteria may apply.