Status:
COMPLETED
A Single-Center Evaluation of the Pattern of Allergic Signs and Symptoms During 4 Weeks in Ragweed Season
Lead Sponsor:
ORA, Inc.
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- Subjects must:
- be willing and able to read, sign, and date the informed consent and HIPAA documents prior to initiation of Visit 1 procedures or exams;
- be at least 18 years of age;
- be willing to avoid disallowed medication, such as anti-allergy therapies
- have a positive history of ocular allergies and a positive skin test reaction to ragweed within the past 24 months;
- have a calculated logMAR visual acuity score using the ETDRS Chart of 0.60 or better in each eye at Visit 1;
Exclusion
- Subjects may not:
- have preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, clinically significant blepharitis, follicular conjunctivitis and iritis);
- have had any ocular infection within the last 30 days;
- have a positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears);
- wear contact lenses to each office visit; Note: Subjects will be allowed to use cold compresses.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00982163
Start Date
August 1 2008
End Date
September 1 2009
Last Update
September 23 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ORA, Inc.
North Andover, Massachusetts, United States, 01845