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

This study has been withdrawn prior to enrollment.
(Study was never initiated due to company decision. No study subjects were ever enrolled or treated.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01284166
First received: January 25, 2011
Last updated: July 17, 2013
Last verified: July 2013

January 25, 2011
July 17, 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 ] [ Designated as safety issue: No ]
Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01284166
Dorzo-Brimo-Timo/2010
No
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