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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01241240
First received: November 12, 2010
Last updated: September 4, 2014
Last verified: September 2014

November 12, 2010
September 4, 2014
March 2011
September 2013   (final data collection date for primary outcome measure)
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.
Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01241240 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Mean Worse Eye IOP [ Time Frame: Baseline, Weeks 1, 2, 4 and 8 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.
  • Mean Worse Eye IOP [ Time Frame: Weeks 1, 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.
  • 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.
 
Completed
192
September 2013
September 2013   (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 information is only displayed when the study is recruiting subjects
Colombia,   Mexico
 
NCT01241240
192024-063
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
September 2014

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