Safety and Intraocular Pressure (IOP) Lowering Effect of AL-59412C

A Proof of Concept Study to Assess the Safety and IOP-Lowering Effect of AL-59412C Injected Intravitreally

The purpose of this study was to assess the safety and efficacy of AL-59412C injected intravitreally relative to Vehicle.

Study Overview

• Status: Terminated
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: AL-59412C injectable solution; Drug: Travoprost injectable solution; Drug: AL-59412C Vehicle

• Study Type: Interventional
• Enrollment (Actual): 4
• 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:

• Diagnosis of primary open-angle glaucoma or ocular hypertension.
• Retinal pathology (eg, retinal degeneration), anterior ischemic optic neuropathy, or vascular occlusion resulting in poor vision in the study eye.
• Able to discontinue all intraocular-lowering (IOP) medications according to the minimum washout period, based upon the class of medication.
• Mean washed out IOP ≥ 24 millimeters mercury (mmHg) to ≤ 36 mmHg at 8 AM in the study eye on two separate Eligibility Visits.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Lens/corneal/vitreal opacity preventing adequate posterior segment visualization of the study eye.
• Current or recent (within 30 days) use of any drug that may prolong the QT interval.
• Poor vision resulting from advanced glaucoma in the study eye.
• Intraocular surgery within the past 6 months in the study eye.
• Ocular laser surgery within the past 3 months in the study eye.
• 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AL-59412C Concentration 1; AL-59412C injectable solution, single intravitreal injection	Drug: AL-59412C injectable solution; Concentration 1 and Concentration 2
Experimental: AL-59412C Concentration 2; AL-59412C injectable solution, single intravitreal injection	Drug: AL-59412C injectable solution; Concentration 1 and Concentration 2
Active Comparator: Travoprost; Travoprost injectable solution, single intravitreal injection	Drug: Travoprost injectable solution
Placebo Comparator: Vehicle; AL-59412C Vehicle, single intravitreal injection	Drug: AL-59412C Vehicle; Inactive ingredients used as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection	IOP was measured by Goldman applanation tonometry at protocol-specified timepoints, up to 24 hours post-injection.	Time to event, up to 24 hours post-injection

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Theresa Landry, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: March 4, 2011
• First Submitted That Met QC Criteria: March 9, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Estimate): October 25, 2013
• Last Update Submitted That Met QC Criteria: September 26, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: intravitreal injection; open-angle glaucoma; ocular hypertension; intraocular pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: C-10-038