Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: Olopatadine 0.1% (Drug); Tranilast 0.5% (Drug); Placebo (Olopatadine) (Drug); Placebo (Tranilast) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research
Summary
To evaluate the efficacy of olopatadine 0. 1% using the OHIO Chamber in patients with
seasonal allergic conjunctivitis.
Clinical Details
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
Secondary outcome: Change in Total Score in Ocular Symptom Questionnaire
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining
consent).
2. 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.
3. 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.
4. Cases who gave consent on study participation of their own free will in writing, with
understanding the contents of the said study.
Exclusion Criteria:
1. Cases with an ocular disease that requires treatment other than allergic
conjunctivitis.
2. Cases with an inflammatory ocular disease in the external/anterior part of the eye
that may affect drug efficacy evaluation.
3. Cases with a respiratory disease such as bronchial asthma other than allergic
rhinitis.
4. Cases with past history of anaphylaxis.
5. Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
6. Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
7. Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to
be pregnant during the study period.
8. Other cases who are judged ineligible for participation in the main study by the
doctor in charge of the study.
Locations and Contacts
Additional Information
Starting date: July 2008
Last updated: May 29, 2012
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