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Evaluating Patients With Eye Allergies and Determining if There Are Also Dry Eyes

Sponsor
Schwartz Laser Eye Center (Other)
Overall Status
Completed
CT.gov ID
NCT01679015
Collaborator
Allergan (Industry)
250
Enrollment
1
Location
18
Duration (Months)
13.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Concomitant Dry Eye in Patients With Ocular Allergy: an Under Recognized and Poorly Managed Syndrome
    Study Start Date :
    Aug 1, 2012
    Actual Primary Completion Date :
    Feb 1, 2014
    Actual Study Completion Date :
    Feb 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Dry Eyes, Eye Allergies

    Patients with ocular allergies and those with dry eyes.

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of dry eye in an allergic population presenting to a high volume optometry practice [up to 2 years]

    Secondary Outcome Measures

    1. Prevalence of allergic patients with moderate to severe ocular signs and symptoms [up to 2 years]

    Eligibility Criteria

    Criteria

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

    • Ability to give informed consent

    • Males and females at least 18 years of age

    • Personal history of allergic disorders including but not limited to allergic conjunctivitis, allergic rhinitis, contact dermatitis and other eczema, and asthma

    • Diagnosis of allergic conjunctivitis

    • Presence of any of the following signs including conjunctival redness and papillae, chemosis, red edematous eyelids, reduced tear clearance, reduced TBUT, vital staining, stringy discharge, and/or symptoms including ocular itching, burning and tearing, runny nose or itchy throat

    Exclusion Criteria:

    • Active ocular or systemic infection

    • History of ocular infection within past 6 months

    • Presence of punctal plugs

    • Recent ocular surgery within past 6 months

    • Current use of chemotherapeutic agents

    • Presence of ocular trauma

    • Inability to give informed consent

    • Women who are pregnant, nursing or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Schwartz Laser Eye Center Scottsdale Arizona United States 85260

    Sponsors and Collaborators

    • Schwartz Laser Eye Center
    • Allergan

    Investigators

    • Principal Investigator: Marc R Bloomenstein, O.D., Schwartz Laser Eye Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marc R.Bloomenstein, O.D., Schwartz Laser Eye Center
    ClinicalTrials.gov Identifier:
    NCT01679015
    Other Study ID Numbers:
    • AL-001
    First Posted:
    Sep 5, 2012
    Last Update Posted:
    Jun 3, 2016
    Last Verified:
    Jan 1, 2013
    Keywords provided by Marc R.Bloomenstein, O.D., Schwartz Laser Eye Center
    Burning
    Dryness
    Itching
    Blurry Vision
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Conjunctivitis
    Conjunctivitis, Allergic

    Study Results

    No Results Posted as of Jun 3, 2016