AL-54478 Proof of Concept Study

Phase 2

Completed

• Conditions: Open-angle Glaucoma (OAG); Ocular Hypertension (OHT)
• Interventions: Drug: AL-54478 Vehicle; Drug: AL-54478 0.005%; Drug: Latanoprost 0.005%

• Registration Number: NCT01318252
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-18
• Study Start: 2011-06
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-28
• Disposition First Submitted QC: 2014-07-28
• Last Update Submitted: 2014-07-28
• Disposition First Posted: 2014-07-31
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	AL-54478 Vehicle	AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing
AL-54478	AL-54478 0.005%	AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing
Latanoprost	Latanoprost 0.005%	Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing

Primary Outcome Measures

Name	Time	Method
24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing	Day 14