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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

Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


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.

Clinical Details

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from Baseline in Intraocular Pressure (IOP)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: July 2013
Last updated: July 17, 2013

Page last updated: August 23, 2015

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