Status:

COMPLETED

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

Lead Sponsor:

Alcon Research

Conditions:

Allergic Conjunctivitis

Eligibility:

All Genders

20+ years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00818805

Start Date

July 1 2008

Last Update

June 4 2012

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