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

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ClinicalTrials.gov Identifier: NCT01312454
Recruitment Status : Terminated (Management decision)
First Posted : March 10, 2011
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : June 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Travoprost

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection [ Time Frame: Time to event, up to 24 hours post-injection ]
    IOP was measured by Goldman applanation tonometry at protocol-specified timepoints, up to 24 hours post-injection.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312454


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01312454     History of Changes
Other Study ID Numbers: C-10-038
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Travoprost
Antihypertensive Agents