Back to results24 Hour IOP Lowering Efficacy of AL-3789
Primary Purpose
Open-angle Glaucoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AL-3789 Sterile Suspension
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Pregnant, intend to become pregnant, breastfeeding.
- Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
- Any form of glaucoma other than open-angle glaucoma.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Inglewood
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AL-3789
No treatment
Arm Description
AL-3789 Sterile Suspension, single depot administration of 0.8 mL in the study eye
Fellow eye, as randomized
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure (IOP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00643669
Brief Title
24 Hour IOP Lowering Efficacy of AL-3789
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)
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 objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-3789
Arm Type
Experimental
Arm Description
AL-3789 Sterile Suspension, single depot administration of 0.8 mL in the study eye
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Fellow eye, as randomized
Intervention Type
Drug
Intervention Name(s)
AL-3789 Sterile Suspension
Intervention Description
Single administration by anterior juxtascleral depot
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP)
Time Frame
Day 28, Up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Pregnant, intend to become pregnant, breastfeeding.
Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
Any form of glaucoma other than open-angle glaucoma.
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Inglewood
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
12. IPD Sharing Statement
Learn more about this trial
24 Hour IOP Lowering Efficacy of AL-3789
We'll reach out to this number within 24 hrs