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

Phase 4

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Placebo (Tranilast); Drug: Olopatadine 0.1%; Drug: Tranilast 0.5%; Drug: Placebo (Olopatadine)

• Registration Number: NCT00818805
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2008-07
• Study First Submitted: 2009-01-07
• Study First Submitted QC: 2009-01-07
• Study First Posted: 2009-01-08
• Results First Submitted: 2009-12-03
• Status Verified: 2010-03
• Results First Submitted QC: 2010-03-11
• Results First Posted: 2010-03-15
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo (Tranilast)	Placebo (Tranilast)	Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
Olopatadine 0.1% one eye	Olopatadine 0.1%	Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye
Tranilast 0.5% one eye	Tranilast 0.5%	Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
Placebo (Olopatadine)	Placebo (Olopatadine)	Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye

Primary Outcome Measures

Name	Time	Method
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire	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 Outcome Measures

Name	Time	Method
Change in Total Score in Ocular Symptom Questionnaire	15-180 min.