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

NCT01312454 | Terminated Phase 2

• 1 other identifier: C-10-038
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Open-angle Glaucoma; Ocular Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

AL-59412C Concentration 1

EXPERIMENTAL

AL-59412C injectable solution, single intravitreal injection

Drug: AL-59412C injectable solution

AL-59412C Concentration 2

EXPERIMENTAL

AL-59412C injectable solution, single intravitreal injection

Drug: AL-59412C injectable solution

Travoprost

ACTIVE COMPARATOR

Travoprost injectable solution, single intravitreal injection

Drug: Travoprost injectable solution

Vehicle

PLACEBO COMPARATOR

AL-59412C Vehicle, single intravitreal injection

Drug: AL-59412C Vehicle

Interventions

AL-59412C injectable solution DRUG

Concentration 1 and Concentration 2

AL-59412C Concentration 1; AL-59412C Concentration 2

Travoprost injectable solution DRUG

Travoprost

AL-59412C Vehicle DRUG

Inactive ingredients used as placebo

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Theresa Landry, PhD

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 10, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 25, 2013

Record last verified: 2013-09