Back to resultsEfficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Olopatadine 0.1%
Tranilast 0.5%
Placebo (Olopatadine)
Placebo (Tranilast)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
- 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.
- 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.
- Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.
Exclusion Criteria:
- Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
- Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
- Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
- Cases with past history of anaphylaxis.
- Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
- Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
- Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
- Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Olopatadine 0.1% one eye
Tranilast 0.5% one eye
Placebo (Olopatadine)
Placebo (Tranilast)
Arm Description
Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye
Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye
Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Total Score in Ocular Symptom Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00818805
Brief Title
Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olopatadine 0.1% one eye
Arm Type
Experimental
Arm Description
Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye
Arm Title
Tranilast 0.5% one eye
Arm Type
Experimental
Arm Description
Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
Arm Title
Placebo (Olopatadine)
Arm Type
Placebo Comparator
Arm Description
Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye
Arm Title
Placebo (Tranilast)
Arm Type
Placebo Comparator
Arm Description
Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
Intervention Type
Drug
Intervention Name(s)
Olopatadine 0.1%
Intervention Description
one drop in one eye
Intervention Type
Drug
Intervention Name(s)
Tranilast 0.5%
Intervention Description
one drop in one eye
Intervention Type
Drug
Intervention Name(s)
Placebo (Olopatadine)
Intervention Description
one drop in contralateral eye
Intervention Type
Drug
Intervention Name(s)
Placebo (Tranilast)
Intervention Description
one drop in contralateral eye
Primary Outcome Measure Information:
Title
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
Description
Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.
Time Frame
0-180 minutes after entering the examination room
Secondary Outcome Measure Information:
Title
Change in Total Score in Ocular Symptom Questionnaire
Time Frame
15-180 min.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
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.
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.
Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.
Exclusion Criteria:
Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
Cases with past history of anaphylaxis.
Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.
12. IPD Sharing Statement
Learn more about this trial
Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
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