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 (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00761709
First received: September 25, 2008
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the safety and intraocular pressure (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 Ophthalmic Suspension, 1%
Drug: Latanoprost Ophthalmic Solution, 0.005%
Drug: Vehicle
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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

Enrollment: 104
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-39256
AL-39256 Ophthalmic Suspension, 1%, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.
Drug: AL-39256 Ophthalmic Suspension, 1%
Active Comparator: XALATAN
Latanoprost Ophthalmic Solution, 0.005%, 1 drop in the study eye(s) at 8 PM from the evening bottle (morning bottle contained vehicle and was dosed 1 drop in the study eye(s) at 8 AM) for 4 weeks.
Drug: Latanoprost Ophthalmic Solution, 0.005%
Other Name: XALATAN®
Drug: Vehicle
Inactive ingredients used as a placebo comparator
Placebo Comparator: Vehicle
Inactive ingredients, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.
Drug: Vehicle
Inactive ingredients used as a placebo comparator

  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.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Females of childbearing potential.
  • 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: NCT00761709

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry, Ph.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00761709     History of Changes
Other Study ID Numbers: C-08-28
Study First Received: September 25, 2008
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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 July 24, 2014