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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: May 6, 2013
Last verified: October 2012
History of Changes
  Purpose

The primary objectives of the study are to assess the safety and efficacy of AL-59412C compared to Vehicle.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
 Drug: AL-59412C Concentration 1
Drug: Travoprost
Other: Vehicle
Drug: AL-59412C Concentration 2
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Travoprost
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Intraocular pressure [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Change from base-line


Enrollment: 3
Study Start Date: April 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-59412C Concentration 1
AL-59412C Concentration 1
 Drug: AL-59412C Concentration 1
AL-59412C Concentration 1
Experimental: Travoprost
Travoprost
 Drug: Travoprost
Travoprost
Placebo Comparator: Vehicle
Vehicle
 Other: Vehicle
Vehicle
Experimental: AL-59412C Concentration 2
AL-59412C Concentration 2
 Drug: AL-59412C Concentration 2
AL-59412C Concentration 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age 18 years or older with primary open-angle glaucoma or ocular hypertension
  • Patients with retinal pathology (eg, retinal degeneration), anterior ischemic optic neuropathy, or vascular occlusion resulting in poor vision in the study eye.
  • Patients able to discontinue all IOP-lowering medications according to the minimum washout period, based upon the class of medication they are taking,
  • Mean washed out IOP ≥ 24 mmHg to ≤ 36 mmHg at 8 AM in the study eye on two separate Eligibility Visits

Exclusion Criteria:

  • Lens/corneal/vitreal opacity preventing adequate posterior segment visualization of the study eye
  • Current or recent (within 30 days) use of any drugs that may prolong the QT interval
  • Patients with 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312454

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
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: May 6, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
AL-59412C
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 June 17, 2013