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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Marc R.Bloomenstein, Schwartz Laser Eye Center
ClinicalTrials.gov Identifier:
NCT01679015
First received: August 20, 2012
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Allergy Pinkeye
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of allergic patients with moderate to severe ocular signs and symptoms [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marc R.Bloomenstein, O.D., Schwartz Laser Eye Center
ClinicalTrials.gov Identifier: NCT01679015     History of Changes
Other Study ID Numbers: AL-001
Study First Received: August 20, 2012
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Schwartz Laser Eye Center:
Burning
Dryness
Itching
Blurry Vision

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

ClinicalTrials.gov processed this record on June 18, 2013