Back to resultsSafety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-39256 Ophthalmic Suspension, 1%
Latanoprost Ophthalmic Solution, 0.005%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open Angle Glaucoma, Ocular Hypertension
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
AL-39256
XALATAN
Vehicle
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Mean change from baseline in IOP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00761709
Brief Title
Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Open Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-39256
Arm Type
Experimental
Arm Description
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.
Arm Title
XALATAN
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AL-39256 Ophthalmic Suspension, 1%
Intervention Type
Drug
Intervention Name(s)
Latanoprost Ophthalmic Solution, 0.005%
Other Intervention Name(s)
XALATAN®
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Inactive ingredients used as a placebo comparator
Primary Outcome Measure Information:
Title
Mean change from baseline in IOP
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Landry, Ph.D.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension
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