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

This study has been completed.
Information provided by (Responsible Party):
Marc R.Bloomenstein, Schwartz Laser Eye Center Identifier:
First received: August 20, 2012
Last updated: June 2, 2016
Last verified: January 2013
Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes.

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 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 ]

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)
Dry Eyes, Eye Allergies
Patients with ocular allergies and those with dry eyes.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01679015

United States, Arizona
Schwartz Laser Eye Center
Scottsdale, Arizona, United States, 85260
Sponsors and Collaborators
Schwartz Laser Eye Center
Principal Investigator: Marc R Bloomenstein, O.D. Schwartz Laser Eye Center
  More Information

Responsible Party: Marc R.Bloomenstein, O.D., Schwartz Laser Eye Center Identifier: NCT01679015     History of Changes
Other Study ID Numbers: AL-001 
Study First Received: August 20, 2012
Last Updated: June 2, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Schwartz Laser Eye Center:
Blurry Vision

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Hypersensitivity, Immediate
Immune System Diseases processed this record on October 21, 2016