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

March 4, 2011
September 26, 2013
June 2011
January 2012   (final data collection date for primary outcome measure)
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.
Safety [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Change from base-line of: best corrected visual acuity, slit-lamp examination, urinalysis, hematology and serum chemistry.
Complete list of historical versions of study NCT01312454 on ClinicalTrials.gov Archive Site
Not Provided
Intraocular pressure [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Change from base-line
Not Provided
Not Provided
 
Safety and Intraocular Pressure (IOP) Lowering Effect of AL-59412C
A Proof of Concept Study to Assess the Safety and IOP-Lowering Effect of AL-59412C Injected Intravitreally

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Open-angle Glaucoma
  • Ocular Hypertension
  • Drug: AL-59412C injectable solution
    Concentration 1 and Concentration 2
  • Drug: Travoprost injectable solution
  • Drug: AL-59412C Vehicle
    Inactive ingredients used as placebo
  • Experimental: AL-59412C Concentration 1
    AL-59412C injectable solution, single intravitreal injection
    Intervention: Drug: AL-59412C injectable solution
  • Experimental: AL-59412C Concentration 2
    AL-59412C injectable solution, single intravitreal injection
    Intervention: Drug: AL-59412C injectable solution
  • Active Comparator: Travoprost
    Travoprost injectable solution, single intravitreal injection
    Intervention: Drug: Travoprost injectable solution
  • Placebo Comparator: Vehicle
    AL-59412C Vehicle, single intravitreal injection
    Intervention: Drug: AL-59412C Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01312454
C-10-038
No
Alcon Research
Alcon Research
Not Provided
Study Director: Theresa Landry, PhD Alcon Research
Alcon Research
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP