Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00761709
First received: September 25, 2008
Last updated: March 23, 2009
Last verified: March 2009
  Purpose

This study will evaluate the safety and IOP-lowering efficacy of AL-39256 in Patients with Open-Angle Glaucoma or Ocular Hypertension


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
Drug: AL-39256
Drug: Latanoprost Ophthalmic Solution, 0.005%
Drug: Placebo (Vehicle Solution)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean IOP from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AL-39256 Ophthalmic Suspension, 1%
Drug: AL-39256
AL-39256 Ophthalmic Suspension, 1%
Active Comparator: 2
Latanoprost Ophthalmic Solution, 0.005%
Drug: Latanoprost Ophthalmic Solution, 0.005%
Latanoprost Ophthalmic Solution, 0.005%
Placebo Comparator: 3
Vehicle
Drug: Placebo (Vehicle Solution)
Ophthalmic solution vehicle

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Females of childbearing potential
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761709

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: Jame Teague, Alcon
ClinicalTrials.gov Identifier: NCT00761709     History of Changes
Other Study ID Numbers: C-08-28
Study First Received: September 25, 2008
Last Updated: March 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Open
Angle
Glaucoma
Ocular Hypertension

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

ClinicalTrials.gov processed this record on April 17, 2014