Back to resultsSafety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Primary Purpose
Glaucoma, Open-Angle, Ocular Hypertension
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)
timolol ophthalmic solution 0.5%
AGN-207281 vehicle ophthalmic solution (Placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria:
- Ocular hypertension or primary open-angle glaucoma in each eye
- Requires IOP-lowering therapy in both eyes
- Visual acuity score of 20/100 or better in each eye
Exclusion Criteria:
- Experienced significant weight change (over 10 pounds) within 60 days
- History of alcohol or drug addiction
- History of migraines or frequent headaches
- Anticipated wearing of contact lenses during the study
- Required chronic use of ocular medications during study
- Eye surgery within 6 months
- Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
- Use of oral, intramuscular, intravenous corticosteroids within 21 days
- Use of ophthalmic corticosteroids within 2 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Placebo Comparator
Arm Label
AGN-207281 ophthalmic solution
Timolol ophthalmic solution 0.5%
Placebo
Arm Description
AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
timolol ophthalmic solution 0.5%
AGN-207281 vehicle ophthalmic solution (Placebo)
Outcomes
Primary Outcome Measures
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14
Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).
Secondary Outcome Measures
Mean Concentration of AGN-207281 in Plasma at Day 7
Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.
Mean Concentration of AGN-207281 in Plasma at Day 14
Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01215786
Brief Title
Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN-207281 ophthalmic solution
Arm Type
Other
Arm Description
AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
Arm Title
Timolol ophthalmic solution 0.5%
Arm Type
Active Comparator
Arm Description
timolol ophthalmic solution 0.5%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
AGN-207281 vehicle ophthalmic solution (Placebo)
Intervention Type
Drug
Intervention Name(s)
AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)
Intervention Description
One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days.
Intervention Type
Drug
Intervention Name(s)
timolol ophthalmic solution 0.5%
Intervention Description
One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days
Intervention Type
Drug
Intervention Name(s)
AGN-207281 vehicle ophthalmic solution (Placebo)
Intervention Description
One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.
Primary Outcome Measure Information:
Title
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14
Description
Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).
Time Frame
Baseline, Day 14
Secondary Outcome Measure Information:
Title
Mean Concentration of AGN-207281 in Plasma at Day 7
Description
Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.
Time Frame
Day 7
Title
Mean Concentration of AGN-207281 in Plasma at Day 14
Description
Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular hypertension or primary open-angle glaucoma in each eye
Requires IOP-lowering therapy in both eyes
Visual acuity score of 20/100 or better in each eye
Exclusion Criteria:
Experienced significant weight change (over 10 pounds) within 60 days
History of alcohol or drug addiction
History of migraines or frequent headaches
Anticipated wearing of contact lenses during the study
Required chronic use of ocular medications during study
Eye surgery within 6 months
Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
Use of oral, intramuscular, intravenous corticosteroids within 21 days
Use of ophthalmic corticosteroids within 2 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
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