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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014