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Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00809848
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : October 18, 2013
Last Update Posted : October 18, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Glaucoma Drug: AGN-210669 ophthalmic solution, 0.075% Drug: AGN-210669 ophthalmic solution, 0.05% Drug: AGN-210669 ophthalmic solution, 0.025% Drug: bimatoprost ophthalmic solution 0.03% Drug: AGN-210669 vehicle ophthalmic solution Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arms and Interventions
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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.
 Drug: 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.
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.
 Drug: 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.
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.
 Drug: 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.
Active Comparator: bimatoprost ophthalmic solution 0.03%
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
 Drug: bimatoprost ophthalmic solution 0.03%
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
Other Name: Lumigan®
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.
 Drug: AGN-210669 vehicle ophthalmic solution
AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809848


Locations
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United States, California
Artesia, California, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00809848    
Other Study ID Numbers: 210669-003
First Posted: December 17, 2008    Key Record Dates
Results First Posted: October 18, 2013
Last Update Posted: October 18, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Eye Diseases
Bimatoprost
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents