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Completed

NCT Number: NCT00985075

A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinoconjunctivitis Following Exposure in the Allergen BioCube

The objective of this study is to evaluate ocular and nasal signs and symptoms in patients with seasonal allergic rhinoconjunctivitis following allergen exposure in the Allergen BioCube.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmic Research Associates, Inc

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be at least 18 years of age;
  • if female, cannot be pregnant or nursing;
  • have a history of ocular and nasal allergy and a positive skin test reaction to one of the allergens tested within the past 24 months;

Exclusion criteria

  • have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the National Heart, Blood and Lung Institute classification;
  • have a compromised lung function;
  • have any ocular condition that could affect the subject's health or the study parameters;
  • have any presence of active ocular or sinus infection;
  • have significant nasal conditions;
  • have any significant illness that could be expected to interfere with the subject's health or with the study parameters
  • use specified disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies) during the study or appropriate pre-study washout period;
  • have used an investigational drug or device within 30 days of starting the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;

Treatment and study plan

Primary outcomes

  1. Ocular Itching

    Time frame: At specified timepoints for up to 3 hours

  2. Conjunctival Redness

    Time frame: At specified timepoints for up to 3 hours

  3. Total Ocular Symptom Score (TOSS)of ocular itching and redness

  4. Total Nasal Symptom Score (TNSS) of nasal symptoms

Secondary outcomes

  1. Ciliary and episcleral redness

    Time frame: At specified timepoints for up to 3 hours

  2. Chemosis

    Time frame: At specified timepoints for up to 3 hours

  3. Lid Swelling

    Time frame: At specified timepoints for up to 3 hours

  4. Tearing

    Time frame: At specified timepoints for up to 3 hours

  5. Nasal Itching

    Time frame: At specified timepoints for up to 3 hours

  6. Sneezing

    Time frame: At specified timepoints for up to 3 hours

  7. Rhinorrhea

    Time frame: At specified timepoints for up to 3 hours

  8. Nasal Congestion

    Time frame: At specified timepoints for up to 3 hours

Sponsors and collaborators

Lead sponsor

ORA, Inc.

Industry

Registry information

Official study title

A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinitis and Conjunctivitis Following Allergen Exposure in the Allergen BioCube

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 28, 2009
Registry last updated
Sep 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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