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

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

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


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.


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

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

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:
Blurry Vision

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

ClinicalTrials.gov processed this record on April 17, 2014