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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No