search
Back to results

Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

Primary Purpose

Allergic Conjunctivitis

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

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

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

Inclusion Criteria: History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model Exclusion Criteria: Under 10 years of age

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Olopatadine Hydrochloride 0.2%

    Vehicle

    Arm Description

    Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks

    Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks

    Outcomes

    Primary Outcome Measures

    Daily ocular itching and redness scores

    Secondary Outcome Measures

    Percentage of patients with daily ocular itching and redness scores of 0

    Full Information

    First Posted
    May 30, 2006
    Last Updated
    August 10, 2017
    Sponsor
    Alcon Research
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00331500
    Brief Title
    Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis
    Official Title
    A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 18, 2006 (Actual)
    Primary Completion Date
    July 27, 2006 (Actual)
    Study Completion Date
    July 27, 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Olopatadine Hydrochloride 0.2%
    Arm Type
    Experimental
    Arm Description
    Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine Hydrochloride Ophthalmic Solution Vehicle
    Intervention Description
    Inactive ingredients used as a placebo comparator
    Primary Outcome Measure Information:
    Title
    Daily ocular itching and redness scores
    Time Frame
    Up to Day 14
    Secondary Outcome Measure Information:
    Title
    Percentage of patients with daily ocular itching and redness scores of 0
    Time Frame
    Up to Day 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model Exclusion Criteria: Under 10 years of age
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alcon, A Novartis Company
    Organizational Affiliation
    Alcon, a Novartis Company
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    Citation
    https://www.ncbi.nlm.nih.gov/pubmed/23379201
    Results Reference
    result

    Learn more about this trial

    Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

    We'll reach out to this number within 24 hrs