Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT ID: NCT01291108
Last Updated: 2013-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
125 participants
INTERVENTIONAL
2011-04-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
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.
AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
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.
AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost vehicle
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
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.
AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
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.
bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost vehicle
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
Interventions
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AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost vehicle
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Requires bilateral treatment with an IOP-lowering medication
* Best corrected visual acuity of 20/100 or better in each eye
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Austin, Texas, United States
Countries
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Other Identifiers
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210669-013
Identifier Type: -
Identifier Source: org_study_id