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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01312454
• Other study ID #: C-10-038
• Status: Terminated
• Phase: Phase 2
• First received: March 4, 2011
• Last updated: September 26, 2013
• Start date: June 2011
• Est. completion date: January 2012

Study information

• Verified date: September 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• AL-59412C injectable solution
Concentration 1 and Concentration 2
• Travoprost injectable solution

• AL-59412C Vehicle
Inactive ingredients used as placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No