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This study has been withdrawn prior to enrollment.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

History of Changes

Purpose

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.

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Timolol maleate Brimonidine tartrate Dorzolamide Dorzolamide hydrochloride

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]


Enrollment:	0
Study Start Date:	July 2013
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284166

Sponsors and Collaborators

Allergan

Investigators


Study Director:	Medical Director	Allergan

More Information


Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01284166 History of Changes
Other Study ID Numbers:	Dorzo-Brimo-Timo/2010
Study First Received:	January 25, 2011
Last Updated:	July 17, 2013
Health Authority:	India: Drugs Controller General of India

Additional relevant MeSH terms:


Hypertension Glaucoma Ocular Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Pharmaceutical Solutions Timolol Dorzolamide Brimonidine Tartrate Ophthalmic Solutions Adrenergic beta-Antagonists	Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Carbonic Anhydrase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016

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