- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00809848
Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
August 13, 2013 updated by: Allergan
The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma.
Subjects will be followed for 2 weeks.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Artesia, California, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ocular hypertension or primary open-angle glaucoma
- Females of non-childbearing potential
- Subject requires IOP-lowering therapy in both eyes
- IOP ≥ 22 mm Hg and ≤ 34 mm Hg
- Has a visual acuity score of 20/100 or better in each eye
Exclusion Criteria:
- Uncontrolled systemic disease
- Active ocular disease
- Alteration of existing chronic systemic medications
- Known allergy or sensitivity to the study medications
- Ophthalmic corticosteroids
- Visual field loss which in the opinion of the investigator is functionally significant
- History of ocular laser, intraocular surgery, or refractive surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AGN-210669 ophthalmic solution, 0.075%
AGN-210669 non-preserved ophthalmic solution, 0.075%.
One drop in both eyes each morning once-daily for 2 weeks.
|
AGN-210669 non-preserved ophthalmic solution, 0.075%.
One drop in both eyes each morning once-daily for 2 weeks.
|
Experimental: AGN-210669 ophthalmic solution, 0.05%
AGN-210669 non-preserved ophthalmic solution, 0.05%.
One drop in both eyes each morning once-daily for 2 weeks.
|
AGN-210669 non-preserved ophthalmic solution, 0.05%.
One drop in both eyes each morning once-daily for 2 weeks.
|
Experimental: AGN-210669 ophthalmic solution, 0.025%
AGN-210669 non-preserved ophthalmic solution, 0.025%.
One drop in both eyes each morning once-daily for 2 weeks.
|
AGN-210669 non-preserved ophthalmic solution, 0.025%.
One drop in both eyes each morning once-daily for 2 weeks.
|
Active Comparator: bimatoprost ophthalmic solution 0.03%
Bimatoprost ophthalmic solution 0.03%.
One drop in both eyes each morning once-daily for 2 weeks.
|
Bimatoprost ophthalmic solution 0.03%.
One drop in both eyes each morning once-daily for 2 weeks.
Other Names:
|
Placebo Comparator: AGN-210669 vehicle ophthalmic solution
AGN-210669 vehicle non-preserved ophthalmic solution.
One drop in both eyes each morning once-daily for 2 weeks.
|
AGN-210669 vehicle non-preserved ophthalmic solution.
One drop in both eyes each morning once-daily for 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Average Eye Intraocular Pressure (IOP)
Time Frame: Baseline, Day 14 Hour 0
|
IOP is a measurement of the fluid pressure inside the eye.
The average of the 2 eyes is used for the analyses.
A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
|
Baseline, Day 14 Hour 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
Time Frame: Baseline, Day 14
|
IOP is a measurement of the fluid pressure inside the eye.
Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.
|
Baseline, Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
December 16, 2008
First Submitted That Met QC Criteria
December 16, 2008
First Posted (Estimate)
December 17, 2008
Study Record Updates
Last Update Posted (Estimate)
October 18, 2013
Last Update Submitted That Met QC Criteria
August 13, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210669-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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