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Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01216943
First received: October 6, 2010
Last updated: September 21, 2012
Last verified: September 2012
History of Changes

October 6, 2010
September 21, 2012
November 2010
August 2012   (final data collection date for primary outcome measure)
Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01216943 on ClinicalTrials.gov Archive Site
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Not Provided
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Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Twice-daily 0.01% Bimatoprost/0.15% Brimonidine/0.5% Timolol Ophthalmic Solution (Triple Combination) in Patients in India, Who Have Glaucoma or Ocular Hypertension With Elevated IOP, and Are on Twice-daily 0.2% Brimonidine/0.5% Timolol Ophthalmic Solution (Dual Combination) Therapy

This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Experimental: Triple Combination Therapy
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Intervention: Drug: bimatoprost/brimonidine tartrate/timolol fixed combination 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
126
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Glaucoma and/or ocular hypertension in both eyes
  • Requires IOP-lowering treatment in both eyes

Exclusion Criteria:

  • Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
  • Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
  • Use of oral, injectable or topical corticosteroids within 21 days
  • Iridectomy or laser peripheral iridotomy in the study eye within 3 months
  • Uncomplicated cataract surgery in the study eye within 6 months
  • Incisional glaucoma surgery in the study eye within 12 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01216943
192024-049
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
September 2012

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