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

Allergic Conjunctivitis Clinical Trial

Official title:

Concomitant Dry Eye in Patients With Ocular Allergy: an Under Recognized and Poorly Managed Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679015
• Other study ID #: AL-001
• Status: Completed
• Phase: N/A
• First received: August 20, 2012
• Last updated: June 2, 2016
• Start date: August 2012
• Est. completion date: February 2014

Study information

• Verified date: January 2013
• Source: Schwartz Laser Eye Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Dry Eye Syndromes
• Dry Eyes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	Schwartz Laser Eye Center	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Schwartz Laser Eye Center	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of dry eye in an allergic population presenting to a high volume optometry practice		up to 2 years	No
Secondary	Prevalence of allergic patients with moderate to severe ocular signs and symptoms		up to 2 years	No