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

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

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Olopatadine 0.1%; Drug: Tranilast 0.5%; Drug: Placebo (Olopatadine); Drug: Placebo (Tranilast)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olopatadine 0.1% one eye; Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye	Drug: Olopatadine 0.1%; one drop in one eye
Experimental: 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	Drug: Tranilast 0.5%; one drop in one eye
Placebo Comparator: Placebo (Olopatadine); Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye	Drug: Placebo (Olopatadine); one drop in contralateral eye
Placebo Comparator: Placebo (Tranilast); Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye	Drug: Placebo (Tranilast); one drop in contralateral eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Total Score in Ocular Symptom Questionnaire	15-180 min.

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: January 7, 2009
• First Submitted That Met QC Criteria: January 7, 2009
• First Posted (Estimate): January 8, 2009

Study Record Updates

• Last Update Posted (Estimate): June 4, 2012
• Last Update Submitted That Met QC Criteria: May 29, 2012
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: conjunctivitis
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Platelet Aggregation Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Olopatadine Hydrochloride; Tranilast
• Other Study ID Numbers: AL-292ET