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

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

AL-59412C injectable solution

Travoprost injectable solution

AL-59412C Vehicle

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring intravitreal injection, intraocular pressure, open-angle glaucoma, ocular hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

AL-59412C Concentration 1

AL-59412C Concentration 2

Travoprost

Vehicle

Arm Description

AL-59412C injectable solution, single intravitreal injection

Travoprost injectable solution, single intravitreal injection

AL-59412C Vehicle, single intravitreal injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01312454

First Posted

March 4, 2011

Last Updated

September 26, 2013

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01312454

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Terminated

Why Stopped

Management decision

Study Start Date

June 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open-angle Glaucoma, Ocular Hypertension

Keywords

intravitreal injection, intraocular pressure, open-angle glaucoma, ocular hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AL-59412C Concentration 1

Arm Type

Experimental

Arm Description

AL-59412C injectable solution, single intravitreal injection

Arm Title

AL-59412C Concentration 2

Arm Type

Experimental

Arm Description

AL-59412C injectable solution, single intravitreal injection

Arm Title

Travoprost

Arm Type

Active Comparator

Arm Description

Travoprost injectable solution, single intravitreal injection

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

AL-59412C Vehicle, single intravitreal injection

Intervention Type

Drug

Intervention Name(s)

AL-59412C injectable solution

Intervention Description

Concentration 1 and Concentration 2

Intervention Type

Drug

Intervention Name(s)

Travoprost injectable solution

Intervention Type

Drug

Intervention Name(s)

AL-59412C Vehicle

Intervention Description

Inactive ingredients used as placebo

Primary Outcome Measure Information:

Title

Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection

Description

IOP was measured by Goldman applanation tonometry at protocol-specified timepoints, up to 24 hours post-injection.

Time Frame

Time to event, up to 24 hours post-injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Theresa Landry, PhD

Organizational Affiliation

Alcon Research

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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