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Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%
Olopatadine 0.2% Vehicle
Olopatadine 0.1% Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergies, Ocular

Eligibility Criteria

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

Inclusion Criteria:

  • Japanese ethnicity.
  • Seasonal Allergic Conjunctivitis--asymptomatic.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching >0) at the start of any visit.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pataday+Pataday Vehicle

    Patanol+Patanol Vehicle

    Arm Description

    Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye

    Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye

    Outcomes

    Primary Outcome Measures

    Mean Ocular Itching Score

    Secondary Outcome Measures

    Mean Total Redness Score

    Full Information

    First Posted
    September 28, 2009
    Last Updated
    July 28, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00987272
    Brief Title
    Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects
    Official Title
    A Phase III Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the CAC Model of Acute Allergic Conjunctivitis in Japanese Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (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
    The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Conjunctivitis
    Keywords
    Allergies, Ocular

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    267 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pataday+Pataday Vehicle
    Arm Type
    Experimental
    Arm Description
    Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye
    Arm Title
    Patanol+Patanol Vehicle
    Arm Type
    Active Comparator
    Arm Description
    Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
    Other Intervention Name(s)
    PATADAY®
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine Hydrochloride Ophthalmic Solution, 0.1%
    Other Intervention Name(s)
    PATANOL®
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine 0.2% Vehicle
    Intervention Description
    Inactive ingredients used as placebo comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine 0.1% Vehicle
    Intervention Description
    Inactive ingredients used as placebo comparator
    Primary Outcome Measure Information:
    Title
    Mean Ocular Itching Score
    Time Frame
    Day 0 of treatment: 3, 5, and 10 minutes post CAC
    Secondary Outcome Measure Information:
    Title
    Mean Total Redness Score
    Time Frame
    Day 0 of treatment: 3, 10, 20 minutes post-CAC

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Japanese ethnicity. Seasonal Allergic Conjunctivitis--asymptomatic. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching >0) at the start of any visit. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pamela Smith, BS
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects

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