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

NCT ID: NCT01312454

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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Conditions

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Open-angle Glaucoma Ocular Hypertension

Keywords

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intravitreal injection intraocular pressure open-angle glaucoma ocular hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AL-59412C Concentration 1

AL-59412C injectable solution, single intravitreal injection

Group Type EXPERIMENTAL

AL-59412C injectable solution

Intervention Type DRUG

Concentration 1 and Concentration 2

AL-59412C Concentration 2

AL-59412C injectable solution, single intravitreal injection

Group Type EXPERIMENTAL

AL-59412C injectable solution

Intervention Type DRUG

Concentration 1 and Concentration 2

Travoprost

Travoprost injectable solution, single intravitreal injection

Group Type ACTIVE_COMPARATOR

Travoprost injectable solution

Intervention Type DRUG

Vehicle

AL-59412C Vehicle, single intravitreal injection

Group Type PLACEBO_COMPARATOR

AL-59412C Vehicle

Intervention Type DRUG

Inactive ingredients used as placebo

Interventions

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AL-59412C injectable solution

Concentration 1 and Concentration 2

Intervention Type DRUG

Travoprost injectable solution

Intervention Type DRUG

AL-59412C Vehicle

Inactive ingredients used as placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theresa Landry, PhD

Role: STUDY_DIRECTOR

Alcon Research

Countries

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United States

Other Identifiers

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C-10-038

Identifier Type: -

Identifier Source: org_study_id