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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:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

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
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 May 19, 2013