Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01217606
First received: October 7, 2010
Last updated: May 7, 2014
Last verified: May 2014

October 7, 2010
May 7, 2014
January 2011
January 2015   (final data collection date for primary outcome measure)
Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01217606 on ClinicalTrials.gov Archive Site
  • IOP [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • IOP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Not Provided

This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Glaucoma, Open-Angle
  • Ocular Hypertension
  • Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
    One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
  • Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
    One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
    Other Name: COMBIGAN®
  • Experimental: Triple Combination Therapy
    Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
    Intervention: Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
  • Active Comparator: Combigan®
    Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
    Intervention: Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
184
October 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ocular hypertension or primary open-angle glaucoma in each eye
  • Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

  • Required chronic use of ocular medications during the study other than study medication
  • Use of any corticosteroids within 30 days
  • History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit
  • Anticipated wearing of contact lenses during the study
Both
18 Years and older
No
Contact: Allergan Inc. clinicaltrials@allergan.com
Brazil
 
NCT01217606
192024-062
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP