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A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01272089
Collaborator
(none)
300
Enrollment
1
Location
1
Arm
7
Duration (Months)
42.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.

Condition or Disease Intervention/Treatment Phase
  • Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pataday

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week

Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week
Other Names:
  • Pataday

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Patient Satisfaction [Day 7]

      As assessed by the subject on a questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • History (within the past 24 months) of allergic conjunctivitis.

    • Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug.

    • Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).

    • Other protocol-defined inclusion criteria may apply.

    Exclusion Criteria:

    • Contraindications or hypersensitivity to the use of the study medication or its components.

    • Inability or unwillingness to follow all study instructions and complete study visits as required.

    • Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit.

    • A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).

    • Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination.

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kolkata India 700020

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT01272089
    Other Study ID Numbers:
    • C-11-013
    First Posted:
    Jan 7, 2011
    Last Update Posted:
    Sep 18, 2012
    Last Verified:
    Sep 1, 2012
    Additional relevant MeSH terms:
    Conjunctivitis
    Conjunctivitis, Allergic
    Olopatadine Hydrochloride
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Sep 18, 2012