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Patient Preference Study

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AL-3862+timolol ophthalmic suspension
Dorzolamide+timolol ophthalmic solution
Sponsored by
Alcon Research
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:

  • Sign informed consent;
  • Diagnosis of glaucoma or ocular hypertension;
  • On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy);
  • IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye;
  • Pregnant, nursing, or not using highly effective birth control methods;
  • Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study;
  • History of bronchial asthma or severe chronic obstructive pulmonary disease;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    AL-3862+timolol, then COSOPT

    COSOPT, then AL-3862+timolol

    Arm Description

    AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later.

    Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later.

    Outcomes

    Primary Outcome Measures

    Percentage of patients with a stated preference for either study medication

    Secondary Outcome Measures

    Mean ocular discomfort score

    Full Information

    First Posted
    December 17, 2007
    Last Updated
    July 9, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00576342
    Brief Title
    Patient Preference Study
    Official Title
    A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.

    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
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    129 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AL-3862+timolol, then COSOPT
    Arm Type
    Other
    Arm Description
    AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later.
    Arm Title
    COSOPT, then AL-3862+timolol
    Arm Type
    Other
    Arm Description
    Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later.
    Intervention Type
    Drug
    Intervention Name(s)
    AL-3862+timolol ophthalmic suspension
    Intervention Type
    Drug
    Intervention Name(s)
    Dorzolamide+timolol ophthalmic solution
    Other Intervention Name(s)
    COSOPT
    Primary Outcome Measure Information:
    Title
    Percentage of patients with a stated preference for either study medication
    Time Frame
    Day 2
    Secondary Outcome Measure Information:
    Title
    Mean ocular discomfort score
    Time Frame
    Day 1, 1 minute after drop instillation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign informed consent; Diagnosis of glaucoma or ocular hypertension; On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy); IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye; Pregnant, nursing, or not using highly effective birth control methods; Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study; History of bronchial asthma or severe chronic obstructive pulmonary disease; Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    Patient Preference Study

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