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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679015
First Posted: September 5, 2012
Last Update Posted: June 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Marc R.Bloomenstein, Schwartz Laser Eye Center
  Purpose
Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes.

Condition
Dry Eyes Allergic Conjunctivitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Concomitant Dry Eye in Patients With Ocular Allergy: an Under Recognized and Poorly Managed Syndrome

Resource links provided by NLM:


Further study details as provided by Marc R.Bloomenstein, Schwartz Laser Eye Center:

Primary Outcome Measures:
  • Prevalence of dry eye in an allergic population presenting to a high volume optometry practice [ Time Frame: up to 2 years ]

Secondary Outcome Measures:
  • Prevalence of allergic patients with moderate to severe ocular signs and symptoms [ Time Frame: up to 2 years ]

Enrollment: 250
Study Start Date: August 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dry Eyes, Eye Allergies
Patients with ocular allergies and those with dry eyes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be screened from existing patient database.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679015


Locations
United States, Arizona
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
  More Information

Responsible Party: Marc R.Bloomenstein, O.D., Schwartz Laser Eye Center
ClinicalTrials.gov Identifier: NCT01679015     History of Changes
Other Study ID Numbers: AL-001
First Submitted: August 20, 2012
First Posted: September 5, 2012
Last Update Posted: June 3, 2016
Last Verified: January 2013

Keywords provided by Marc R.Bloomenstein, Schwartz Laser Eye Center:
Burning
Dryness
Itching
Blurry Vision

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctivitis, Allergic
Keratoconjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases