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.

Study Overview

• Status: Completed
• Conditions: Open-angle Glaucoma (OAG); Ocular Hypertension (OHT)
• Intervention / Treatment: Drug: AL-54478 0.005%; Drug: Latanoprost 0.005%; Drug: AL-54478 Vehicle

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Ravaughn Williams, Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: March 16, 2011
• First Posted (Estimate): March 18, 2011

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 28, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Elevated IOP
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: C-10-080