Phase 4
N=50
Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00818805 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire — 0.19; 0.11; 0.06; 0.08 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olopatadine 0.1% (Drug); Tranilast 0.5% (Drug); Placebo (Olopatadine) (Drug); Placebo (Tranilast) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire |
0.19; 0.11; 0.06; 0.08; 0.44; 0.25 | — |
| SECONDARY Change in Total Score in Ocular Symptom Questionnaire |
— | — |
Summary
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic 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.
Data sourced from ClinicalTrials.gov (NCT00818805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.