Clinical Trials/NCT01284166

NCT01284166

Withdrawn

Phase 3

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

Allergan0 sitesJuly 2013

ConditionsGlaucoma Ocular Hypertension

Interventionsdorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution

Drugsdorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution

Overview

Phase: Phase 3
Intervention: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution
Conditions: Glaucoma
Sponsor: Allergan
Primary Endpoint: Change from Baseline in Intraocular Pressure (IOP)
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

May 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution

Outcomes

Primary Outcomes

Change from Baseline in Intraocular Pressure (IOP)

Time Frame: Baseline, Week 12

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