A Single-Center Evaluation of the Pattern of Allergic Signs and Symptoms During 4 Weeks in Ragweed Season

Ora, Inc.

Status: Completed

Conditions: Allergic Conjunctivitis

Study type: Observational

Funder types: Industry

Identifiers

NCT00982163

08-003-26

Details and patient eligibility

About

The study was designed to evaluate the pattern of seasonal allergic signs and symptoms consistent with ongoing ocular allergic inflammation during ragweed season. It was hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain subjects.

Full description

Subjects who had a positive skin test to ragweed within 24 months of Visit 1 were instructed to complete a diary, which assessed their allergic signs and symptoms 3 times a day for 4 weeks. During the in-office visits, subjects were asked to completed a quality of life questionnaire, as well as a retrospective and/or prospective eye allergy questionnaire.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must:

  1. be willing and able to read, sign, and date the informed consent and HIPAA documents prior to initiation of Visit 1 procedures or exams;
  2. be at least 18 years of age;
  3. be willing to avoid disallowed medication, such as anti-allergy therapies
  4. have a positive history of ocular allergies and a positive skin test reaction to ragweed within the past 24 months;
  5. have a calculated logMAR visual acuity score using the ETDRS Chart of 0.60 or better in each eye at Visit 1;

Exclusion criteria

• Subjects may not:

  1. have preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, clinically significant blepharitis, follicular conjunctivitis and iritis);
  2. have had any ocular infection within the last 30 days;
  3. have a positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears);
  4. wear contact lenses to each office visit; Note: Subjects will be allowed to use cold compresses.