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

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818805
• Other study ID #: AL-292ET
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2009
• Last updated: May 29, 2012
• Start date: July 2008

Study information

• Verified date: March 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Olopatadine 0.1%
one drop in one eye
• Tranilast 0.5%
one drop in one eye
• Placebo (Olopatadine)
one drop in contralateral eye
• Placebo (Tranilast)
one drop in contralateral eye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire	Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.	0-180 minutes after entering the examination room	No
Secondary	Change in Total Score in Ocular Symptom Questionnaire		15-180 min.	No