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

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: NCT01291108
Recruitment Status : Completed
First Posted : February 8, 2011
Results First Posted : November 6, 2013
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: AGN-210669 Drug: bimatoprost Drug: bimatoprost vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 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: AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
 Drug: AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
Experimental: AGN-210669 + bimatoprost
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
 Drug: AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.

Drug: bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
Other Name: LUMIGAN®
Experimental: AGN-210669 + bimatoprost vehicle
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
 Drug: AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.

Drug: bimatoprost vehicle
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
Active Comparator: bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
 Drug: bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
Other Name: LUMIGAN®
Experimental: bimatoprost + AGN-210669
bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
 Drug: AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.

Drug: bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
Other Name: LUMIGAN®
bimatoprost + bimatoprost vehicle
bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
 Drug: bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
Other Name: LUMIGAN®

Drug: bimatoprost vehicle
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Average Eye IOP [ Time Frame: Baseline, Day 57 ]
    IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are 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). Data are recorded at Hours 0, 4, 8, and 12.


Secondary Outcome Measures :
  1. Change From Baseline in Worse Eye IOP [ Time Frame: Baseline, Day 57 ]
    IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. 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). Data are recorded at Hours 0, 4, 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:

  • Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
  • Requires bilateral treatment with an IOP-lowering medication
  • Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

  • Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
  • Inability to fast for up to 10 hours
  • Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
  • Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
  • Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
  • Anticipated wearing of contact lenses during study
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): NCT01291108


Locations
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United States, Texas
Austin, Texas, 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: NCT01291108    
Other Study ID Numbers: 210669-013
First Posted: February 8, 2011    Key Record Dates
Results First Posted: November 6, 2013
Last Update Posted: November 6, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents