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

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

brimonidine/timolol Fixed-combination monotherapy

dorzolamide/timolol fixed-combination monotherapy

prostaglandin analogue + brimonidine/timolol fixed combination

prostaglandin analogue + dorzolamide/timolol fixed combination

Outcomes

Primary Outcome Measures

Change from baseline in mean IOP

Secondary Outcome Measures

Patient tolerability/comfort measured by Likert scale

Full Information

First Posted
January 13, 2009
Last Updated
January 13, 2009
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00822055
Brief Title
Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
brimonidine/timolol Fixed-combination monotherapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
dorzolamide/timolol fixed-combination monotherapy
Arm Title
3
Arm Type
Active Comparator
Arm Description
prostaglandin analogue + brimonidine/timolol fixed combination
Arm Title
4
Arm Type
Active Comparator
Arm Description
prostaglandin analogue + dorzolamide/timolol fixed combination
Intervention Type
Drug
Intervention Name(s)
brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
Other Intervention Name(s)
Combigan®
Intervention Description
1 drop BID in each eye
Intervention Type
Drug
Intervention Name(s)
dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
Other Intervention Name(s)
Cosopt®
Intervention Description
1 drop BID in each eye
Intervention Type
Drug
Intervention Name(s)
brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
Other Intervention Name(s)
Combigan®
Intervention Description
1 drop BID in each eye
Intervention Type
Drug
Intervention Name(s)
dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
Other Intervention Name(s)
Cosopt®
Intervention Description
1 drop BID in each eye
Primary Outcome Measure Information:
Title
Change from baseline in mean IOP
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient tolerability/comfort measured by Likert scale
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Barrie
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19476406
Citation
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.
Results Reference
derived

Learn more about this trial

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

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