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

Alcon

Status and phase: Completed; Phase 4

Conditions: Allergic Conjunctivitis

Treatments: Drug: Olopatadine 0.1%; Drug: Placebo (Olopatadine); Drug: Tranilast 0.5%; Drug: Placebo (Tranilast)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818805

AL-292ET

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 4 patient groups, including a placebo group

Olopatadine 0.1% one eye

Experimental group

Description:

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

Treatment:

Drug: Olopatadine 0.1%

Tranilast 0.5% one eye

Experimental group

Description:

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

Treatment:

Drug: Tranilast 0.5%

Placebo (Olopatadine)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (Olopatadine)

Placebo (Tranilast)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (Tranilast)