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

Allergan

Status and phase: Completed; Phase 4

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination; Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy; Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination; Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00822055

COM0501

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 4 patient groups

1

Active Comparator group

Description:

brimonidine/timolol Fixed-combination monotherapy

Treatment:

Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination

2

Active Comparator group

Description:

dorzolamide/timolol fixed-combination monotherapy

Treatment:

Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination

3

Active Comparator group

Description:

prostaglandin analogue + brimonidine/timolol fixed combination

Treatment:

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

4

Active Comparator group

Description:

prostaglandin analogue + dorzolamide/timolol fixed combination

Treatment:

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