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

This study has been completed.
Sponsor:
Information provided by:
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT00982163
First received: September 22, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition
Allergic Conjunctivitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by ORA, Inc.:

Primary Outcome Measures:
  • Diary Data [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A community sample of subjects with allergic conjunctivitis and at least 18 years of age were enrolled into the study.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982163

Locations
United States, Massachusetts
ORA, Inc.
North Andover, Massachusetts, United States, 01845
Sponsors and Collaborators
ORA, Inc.
Investigators
Principal Investigator: H. Jerome Crampton, M.D. ORA, Inc.
  More Information

No publications provided

Responsible Party: Paul Gomes, Ophthalmic Research Associates
ClinicalTrials.gov Identifier: NCT00982163     History of Changes
Other Study ID Numbers: 08-003-26
Study First Received: September 22, 2009
Last Updated: September 22, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014