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Completed

NCT Number: NCT00818805

Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)

To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
  • Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.
  • Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.
  • Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.

Exclusion criteria

  • Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
  • Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
  • Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
  • Cases with past history of anaphylaxis.
  • Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
  • Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
  • Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
  • Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.

Treatment and study plan

Olopatadine 0.1%

Drug

one drop in one eye

Tranilast 0.5%

Drug

one drop in one eye

Placebo (Olopatadine)

Drug

one drop in contralateral eye

Placebo (Tranilast)

Drug

one drop in contralateral eye

Primary outcomes

  1. Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire

    Time frame: 0-180 minutes after entering the examination room

    Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.

Secondary outcomes

  1. Change in Total Score in Ocular Symptom Questionnaire

    Time frame: 15-180 min.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
First posted
Jan 8, 2009
Registry last updated
Jun 4, 2012

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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