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

NCT ID: NCT00822055

Last Updated: 2009-01-14

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-11-30

Brief Summary

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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

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

brimonidine/timolol Fixed-combination monotherapy

Group Type ACTIVE_COMPARATOR

brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination

Intervention Type DRUG

1 drop BID in each eye

2

dorzolamide/timolol fixed-combination monotherapy

Group Type ACTIVE_COMPARATOR

dorzolamide hcl 2%/timolol maleate 0.5% fixed combination

Intervention Type DRUG

1 drop BID in each eye

3

prostaglandin analogue + brimonidine/timolol fixed combination

Group Type ACTIVE_COMPARATOR

brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy

Intervention Type DRUG

1 drop BID in each eye

4

prostaglandin analogue + dorzolamide/timolol fixed combination

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

1 drop BID in each eye

Interventions

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brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination

1 drop BID in each eye

Intervention Type DRUG

dorzolamide hcl 2%/timolol maleate 0.5% fixed combination

1 drop BID in each eye

Intervention Type DRUG

brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy

1 drop BID in each eye

Intervention Type DRUG

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

1 drop BID in each eye

Intervention Type DRUG

Other Intervention Names

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Combigan® Cosopt® Combigan® Cosopt®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan, Inc.

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Barrie, Ontario, Canada

Site Status

Countries

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Canada

References

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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. doi: 10.1185/03007990902994041.

Reference Type DERIVED
PMID: 19476406 (View on PubMed)

Other Identifiers

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COM0501

Identifier Type: -

Identifier Source: org_study_id