Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®
NCT ID: NCT01170884
Last Updated: 2019-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2009-12-31
2010-09-30
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
SINGLE
Study Groups
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Combigan® + Lumigan®
COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution
1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours.
Lumigan®
LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops
1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken approximately every 24 hours; mild lubricant eyedrops (Gen Teal® Mild) for masking purposes
Interventions
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fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution
1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours.
bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops
1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken approximately every 24 hours; mild lubricant eyedrops (Gen Teal® Mild) for masking purposes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual Acuity 20/100 or better in both eyes
Exclusion Criteria
* History of any intraocular surgery or glaucoma laser surgery within 3 months
* Contraindication to pupil dilation
* Use of topical, periorbital, intravitreal, or systemic steroid within 3 months
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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Dallas, Texas, United States
Countries
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References
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Myers JS, Vold S, Zaman F, Williams JM, Hollander DA. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials. Clin Ophthalmol. 2014 Mar 27;8:643-52. doi: 10.2147/OPTH.S59197. eCollection 2014.
Other Identifiers
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GMA-COM-09-013
Identifier Type: -
Identifier Source: org_study_id
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