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Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®

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ClinicalTrials.gov Identifier: NCT01170884
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : January 12, 2012
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution Drug: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : December 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Combigan® + Lumigan®
COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
Drug: 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.
Other Names:
  • COMBIGAN®
  • LUMIGAN®

Active Comparator: Lumigan®
LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
Drug: 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 Names:
  • LUMIGAN®
  • Gen Teal® Mild




Primary Outcome Measures :
  1. Mean Diurnal Intraocular Pressure (IOP) at Week 12 [ Time Frame: Week 12 ]
    Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.



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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:

  • Diagnosed with glaucoma or ocular hypertension.
  • Visual Acuity 20/100 or better in both eyes

Exclusion Criteria:

  • Any active ocular disease
  • 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

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): NCT01170884


Locations
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01170884     History of Changes
Other Study ID Numbers: GMA-COM-09-013
First Posted: July 27, 2010    Key Record Dates
Results First Posted: January 12, 2012
Last Update Posted: January 12, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Tetrahydrozoline
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Brimonidine Tartrate, Timolol Maleate Drug Combination
Bimatoprost
Brimonidine Tartrate
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants