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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-04-30

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 randomization process, each subject is allocated to recieve either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjuctive to a prostoglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1, and Month 3 for ophthalmic evaluations.

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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

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 combinatin 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 combinatin 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 yrs.
* Female subjects of childbearing potential must have negative pregnancy test and provide 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 containdicated.
* Subjects who have had introcular 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