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Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01284166
Recruitment Status : Withdrawn (Study was never initiated due to company decision. No study subjects were ever enrolled or treated.)
First Posted : January 26, 2011
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):

January 25, 2011
January 26, 2011
July 18, 2013
July 2013
May 2014   (Final data collection date for primary outcome measure)
Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 12 ]
Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Week 12 ]
Complete list of historical versions of study NCT01284166 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Not Provided
This study will investigate the safety and efficacy of Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol maleate combination therapy.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution
1 drop of Triple Combination Therapy (dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Experimental: Triple Combination Therapy
Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Intervention: Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of ocular hypertension or glaucoma in each eye
  • Requires IOP-lowering treatment in both eyes

Exclusion Criteria:

  • Use of dorzolamide or carbonic anhydrase within 4 weeks
  • Any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye)
  • Required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted)
  • Use of oral, injectable or topical ophthalmic steroids within 21 days
  • Any eye laser surgery within 3 months
  • Any intraocular surgery (eg cataract surgery) within 6 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
India
 
NCT01284166
Dorzo-Brimo-Timo/2010
No
Not Provided
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Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
July 2013

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