Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.

Sponsor:

Information provided by:

Allergan

ClinicalTrials.gov Identifier:

NCT00822055

First received: January 13, 2009

Last updated: NA

Last verified: January 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

January 13, 2009

Last Updated Date

January 13, 2009

Start Date ^ICMJE

May 2005

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in mean IOP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Patient tolerability/comfort measured by Likert scale [ Time Frame: Month 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Official Title ^ICMJE

Not Provided

Brief Summary

This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Open-Angle Glaucoma
Ocular Hypertension

Intervention ^ICMJE

Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
1 drop BID in each eye

Other Name: Combigan®
Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
1 drop BID in each eye

Other Name: Cosopt®
Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
1 drop BID in each eye

Other Name: Combigan®
Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
1 drop BID in each eye

Other Name: Cosopt®

Study Arm (s)

Active Comparator: 1
brimonidine/timolol Fixed-combination monotherapy

Intervention: Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
Active Comparator: 2
dorzolamide/timolol fixed-combination monotherapy

Intervention: Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
Active Comparator: 3
prostaglandin analogue + brimonidine/timolol fixed combination

Intervention: Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
Active Comparator: 4
prostaglandin analogue + dorzolamide/timolol fixed combination

Intervention: Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy

Publications *

Nixon DR, Yan DB, Chartrand JP, Piemontesi RL, Simonyi S, Hollander DA. Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy. Curr Med Res Opin. 2009 Jul;25(7):1645-53.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

November 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female over 18 years
Female subjects of childbearing potential must have negative pregnancy test and practice contraception
Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate
Subjects able to complete questionnaires and provide informed consent

Exclusion Criteria:

Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control
Subjects wherein the study drugs are contraindicated
Subjects who have had intraocular surgery with 6 months (3 months for laser)
Subjects with known side effects/allergy or sensitivity to any component of study treatments
Subjects with any uncontrolled systemic disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00822055

Other Study ID Numbers ^ICMJE

COM0501

Has Data Monitoring Committee

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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