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

NCT ID: NCT00818805

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31

Brief Summary

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

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Olopatadine 0.1% one eye

Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye

Group Type: EXPERIMENTAL

Olopatadine 0.1%

Intervention Type: DRUG

one drop in one eye

Tranilast 0.5% one eye

Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye

Group Type: EXPERIMENTAL

Tranilast 0.5%

Intervention Type: DRUG

one drop in one eye

Placebo (Olopatadine)

Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye

Group Type: PLACEBO_COMPARATOR

Placebo (Olopatadine)

Intervention Type: DRUG

one drop in contralateral eye

Placebo (Tranilast)

Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye

Group Type: PLACEBO_COMPARATOR

Placebo (Tranilast)

Intervention Type: DRUG

one drop in contralateral eye

Interventions

Olopatadine 0.1%

one drop in one eye

Intervention Type: DRUG

Tranilast 0.5%

one drop in one eye

Intervention Type: DRUG

Placebo (Olopatadine)

one drop in contralateral eye

Intervention Type: DRUG

Placebo (Tranilast)

one drop in contralateral eye

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AL-292ET

Identifier Type: -

Identifier Source: org_study_id