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Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT01110499
Recruitment Status : Completed
First Posted : April 26, 2010
Results First Posted : August 5, 2014
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Primary Open-Angle Glaucoma Drug: AGN-210961 Formulation 1 Drug: AGN-210961 Formulation 2 Drug: AGN-210961 Formulation 3 Drug: AGN-210961 Formulation 4 Drug: AGN-210961 Formulation 5 Drug: AGN-210961 Formulation 6 Drug: AGN-210961 Formulation 7 Drug: bimatoprost ophthalmic solution 0.03% Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

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: Part 1, AGN-210961 Formulation 1
AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
 Drug: AGN-210961 Formulation 1
AGN-210961 Formulation 1 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 2
AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
 Drug: AGN-210961 Formulation 2
AGN-210961 Formulation 2 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
 Drug: AGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
 Drug: AGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
 Drug: AGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
 Drug: AGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye once daily for 7 days.
Experimental: Part 2, AGN-210961 Formulation 7
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
 Drug: AGN-210961 Formulation 7
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Active Comparator: Part 2, bimatoprost ophthalmic solution 0.03%
bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
 Drug: bimatoprost ophthalmic solution 0.03%
bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.
Other Name: LUMIGAN®


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Day 7 ]
    IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.

  2. Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) [ Time Frame: Baseline, Day 29 ]
    IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

- Ocular hypertension or primary open-angle glaucoma in each eye

Exclusion Criteria:

  • Any active ocular disease
  • Anticipated wearing of contact lenses during study
  • Anticipated use of artificial tears during study
  • Contraindication to pupil dilatation
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): NCT01110499


Locations
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United States, California
Newport Beach, 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: NCT01110499    
Other Study ID Numbers: 210961-002
First Posted: April 26, 2010    Key Record Dates
Results First Posted: August 5, 2014
Last Update Posted: August 5, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Eye Diseases
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents