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Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of ocular hypertension or glaucoma in each eye
  • Requires IOP-lowering treatment in both eyes

Exclusion Criteria:

  • Use of dorzolamide or carbonic anhydrase within 4 weeks
  • Any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye)
  • Required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted)
  • Use of oral, injectable or topical ophthalmic steroids within 21 days
  • Any eye laser surgery within 3 months
  • Any intraocular surgery (eg cataract surgery) within 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Triple Combination Therapy

    Arm Description

    Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Intraocular Pressure (IOP)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 25, 2011
    Last Updated
    July 17, 2013
    Sponsor
    Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01284166
    Brief Title
    Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was never initiated due to company decision. No study subjects were ever enrolled or treated.
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    May 2014 (Anticipated)
    Study Completion Date
    May 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Allergan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will investigate the safety and efficacy of Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol maleate combination therapy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Triple Combination Therapy
    Arm Type
    Experimental
    Arm Description
    Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution
    Intervention Description
    1 drop of Triple Combination Therapy (dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution) administered to each eye, twice daily for 12 weeks.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Intraocular Pressure (IOP)
    Time Frame
    Baseline, Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of ocular hypertension or glaucoma in each eye Requires IOP-lowering treatment in both eyes Exclusion Criteria: Use of dorzolamide or carbonic anhydrase within 4 weeks Any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye) Required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted) Use of oral, injectable or topical ophthalmic steroids within 21 days Any eye laser surgery within 3 months Any intraocular surgery (eg cataract surgery) within 6 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Allergan
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

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