Allergic Conjunctivitis
Conditions
Keywords
Allergic conjunctivitis
Brief summary
The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.
Interventions
1-2 drops 4 times per day
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Patients whose parents or guardians can issue informed consent * Patients aged over 7 and less than 16 at the baseline * Patients confirmed to show type I allergy * Patients with allergic conjunctivitis * Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)
Exclusion criteria
* Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis * Patients having retinal detachment, diabetic retinopathy or progressive retinal disease * Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury * Patients having received continuous treatment with corticosteroid within 3 months * Patients having received immunotherapy * Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for conjunctivitis or any ophthalmic solution other than the test product * Patients having undergone ocular laser therapy within 3 months * Unilaterally blind patients (best corrected visual acuity: below 0.01) * Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride * Patients necessitating the use of contact lens during the study period * Other patients judged by the attending physician as inappropriate for study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 4 weeks | — |
| Questionnaire about compliance with dosing instructions | 4 weeks | (1;always \>90% 2;often 75-90% 3;sometimes 50-75% 4;seldom \<50%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in score of subjective symptoms and objective findings | 4 weeks | (0;none 1;mild 2;moderate 3;severe) |
| Questionnaire about stinging after instillation | 4 weeks | (1;none 2;mild 3;moderate 4;severe) |
Countries
Japan
Outcome results
None listed