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An Evaluation of Use of Topical Ocular Hypotensive Medication by Compliance

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
travoprost, latanoprost, or bimatoprost
Additional ocular hypotensive medication
Sponsored by
Robin, Alan L., M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma, Compliance

Eligibility Criteria

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

Inclusion Criteria: Currently using one or two topical ocular hypotensive medications Exclusion Criteria: Hypersensitivity to any component of medication

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Compliance.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 19, 2006
    Last Updated
    May 22, 2006
    Sponsor
    Robin, Alan L., M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00329095
    Brief Title
    An Evaluation of Use of Topical Ocular Hypotensive Medication by Compliance
    Official Title
    An Evaluation of Use of Topical Ocular Hypotensive Medication by Electronic Compliance Measures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Robin, Alan L., M.D.

    4. Oversight

    5. Study Description

    Brief Summary
    This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.
    Detailed Description
    This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    travoprost, latanoprost, or bimatoprost
    Intervention Type
    Drug
    Intervention Name(s)
    Additional ocular hypotensive medication
    Primary Outcome Measure Information:
    Title
    Compliance.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Currently using one or two topical ocular hypotensive medications Exclusion Criteria: Hypersensitivity to any component of medication
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alan L. Robin, MD
    Organizational Affiliation
    Alan L. Robin, M.D.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17686450
    Citation
    Robin AL, Novack GD, Covert DW, Crockett RS, Marcic TS. Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use. Am J Ophthalmol. 2007 Oct;144(4):533-40. doi: 10.1016/j.ajo.2007.06.012. Epub 2007 Aug 8.
    Results Reference
    derived

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    An Evaluation of Use of Topical Ocular Hypotensive Medication by Compliance

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