Adjunctive Study of AL-37807 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00620256
First received: February 11, 2008
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
Drug: AL-37807 ophthalmic suspension, 0.1%
Drug: Timolol gel forming solution, 0.5%
Other: AL-37807 ophthalmic solution vehicle
Drug: Latanoprost ophthalmic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change from baseline in intraocular pressure [ Time Frame: Baseline, up to 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: November 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-37807
AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
Drug: AL-37807 ophthalmic suspension, 0.1% Drug: Latanoprost ophthalmic solution
Other Name: XALATAN
Active Comparator: Timolol
Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
Drug: Timolol gel forming solution, 0.5% Drug: Latanoprost ophthalmic solution
Other Name: XALATAN
Placebo Comparator: AL-37807 vehicle
AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
Drug: AL-37807 ophthalmic suspension, 0.1% Other: AL-37807 ophthalmic solution vehicle Drug: Latanoprost ophthalmic solution
Other Name: XALATAN

  Eligibility

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

Inclusion Criteria:

  • Open-angle glaucoma
  • Ocular hypertension
  • Must have been on Xalatan for at least 3 months
  • VA not worse than 0.60
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Age related
  • 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: NCT00620256

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00620256     History of Changes
Other Study ID Numbers: C-07-05
Study First Received: February 11, 2008
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Glaucoma
Hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 23, 2014