allergic conjunctivits
Conditions
Interventions
Patanol Ophthalmic Solution 0.1%
Sponsors
Alcon Japan Ltd.
Fujishima eye clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients whose parents or other guardians can issue informed consent in writing prior to the study 2.Patients aged over 7 and less than 16 at the baseline 3.Patients confirmed to show type I allergy by skin reaction tests (intracutaneous test, scratch test, etc.), antigen-specific IgE antibody assay, neutrophhils in ocular discharge/conjunctival brushing specimen, and so on 4.Patients having inflammatory changes in the conjunctiva 5.Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)
Exclusion criteria
Exclusion criteria: 1.Patients having ocular itching sensation and injection (caused by disease other than allergic conjunctivitis) possibly affecting the evaluation of drug efficacy 2.Patients having retinal detachment, diabetic retinopathy or progressive retinal disease (excluding cases rated by the attending physician as causing no problem in enrollment to the study) 3.Patients with a history of ocular infection (bacterial, viral or fungal), corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury (excluding cases rated by the attending physician as causing no problem in enrollment to the study) 4.Patients having received continuous treatment with corticosteroid (subconjunctival injection) within 3 months (90 days) before acquisition of consent 5.Patients having received immunotherapy (desensitization, immunomodulating therapy, etc.) 6.Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herb preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product 7.Patients having undergone ocular laser therapy within 3 months (90 days) before acquisition of consent or non-laser ocular surgery within 6 months (180 days) after acquisition of consent or planned to receive surgery during the study period 8.Unilaterally blind patients (best corrected visual acuity: below 0.01) 9.Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride 10.Patients necessitating the use of contact lens during the study period 11.Other patients judged by the attending physician as inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Presence/absence of adverse reactions Efficacy: Alleviation in subjective symptoms and objective findings | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Compliance with dosing instructions (checked by interview of subjects during visit) Efficacy: Impressions after doses (checked by interview of subjects during visit) | — |
Countries
Japan
Contacts
Public ContactMiki Uchino
Ryogoku Eye Clinic Ophthalmology Director
Outcome results
None listed