AL-54478 Proof of Concept Study

Study Overview
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Brief Summary
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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.

Conditions
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Open-angle Glaucoma (OAG), Ocular Hypertension (OHT)

Intervention / Treatment
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* Drug: AL-54478 0.005%
* Drug: Latanoprost 0.005%
* Drug: AL-54478 Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL-54478<br>AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing | Drug: AL-54478 0.005%<br> <br> |
| Active Comparator: Latanoprost<br>Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing | Drug: Latanoprost 0.005%<br> <br> |
| Placebo Comparator: Vehicle<br>AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing | Drug: AL-54478 Vehicle<br>* Inactive ingredients used as a placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing |  | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elevated IOP