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

Completed

• Conditions: Allergic Conjunctivitis

• Registration Number: NCT00982163
• Lead Sponsor: ORA, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-09
• Status Verified: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Last Update Submitted: 2009-09-22
• Study First Posted: 2009-09-23
• Last Update Posted: 2009-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diary Data	4 weeks

Trial Locations

Locations (1)

ORA, Inc.; 🇺🇸 North Andover, Massachusetts, United States