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Trial record 74 of 152 for:    Brimonidine

A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT01863953
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Fixed-Combination Bimatoprost/Brimonidine Drug: Bimatoprost Ophthalmic Solution 0.01% Drug: Vehicle Ophthalmic Solution Drug: Brimonidine Tartrate Ophthalmic Solution 0.2% Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Fixed-Combination Bimatoprost/Brimonidine
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
Drug: Fixed-Combination Bimatoprost/Brimonidine
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

Active Comparator: Bimatoprost Ophthalmic Solution 0.01% and Vehicle
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
Drug: Bimatoprost Ophthalmic Solution 0.01%
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.
Other Name: LUMIGAN

Drug: Vehicle Ophthalmic Solution
One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.

Active Comparator: Brimonidine Tartrate Ophthalmic Solution 0.2%
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Other Name: ALPHAGAN




Primary Outcome Measures :
  1. Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) [ Time Frame: Baseline, Day 42 ]
    IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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).


Secondary Outcome Measures :
  1. Change From Baseline in Average Eye Mean Diurnal IOP [ Time Frame: Baseline, Day 14, Day 28 ]
    IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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).

  2. Average Eye Mean Diurnal IOP [ Time Frame: Day 14, Day 28, Day 42 ]
    IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ocular hypertension or glaucoma
  • Requires intraocular pressure (IOP)-lowering therapy

Exclusion Criteria:

  • Cataract surgery in one eye
  • Ocular laser or intraocular surgery within 6 months
  • Refractive surgery in either eye
  • Anticipated use of contact lenses during the study
  • Expected use of artificial tears during the study

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): NCT01863953


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

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01863953     History of Changes
Other Study ID Numbers: 192024-082
First Posted: May 29, 2013    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Brimonidine Tartrate
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Bimatoprost
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs