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

This study has been terminated.
(Management decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01312454
First received: March 4, 2011
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
Drug: AL-59412C injectable solution
Drug: Travoprost injectable solution
Drug: AL-59412C Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Proof of Concept Study to Assess the Safety and IOP-Lowering Effect of AL-59412C Injected Intravitreally

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection [ Time Frame: Time to event, up to 24 hours post-injection ] [ Designated as safety issue: No ]
    IOP was measured by Goldman applanation tonometry at protocol-specified timepoints, up to 24 hours post-injection.


Enrollment: 4
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312454

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01312454     History of Changes
Other Study ID Numbers: C-10-038
Study First Received: March 4, 2011
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
intravitreal injection
intraocular pressure
open-angle glaucoma
ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014