allergic conjunctivitis
Conditions
Interventions
Eyebon AL [Methods] The eyes were washed for 30 seconds with 5 mL of the eyewash solution using the eye cup for commercial eyewash solutions (eye cup attached to Eyebon AL).
No Treatment
Sponsors
Tsurumi University
The Kitasato Institute Ora Japan, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A positive CAC was defined as an itching score of > 2 and a hyperemia score of > 2 in the conjunctival vessel bed in both eyes within 10 (+-1) minutes of receiving the patient's last dose of allergen.
Exclusion criteria
Exclusion criteria: 1. have had a history of allergic hypersensitivity or known hypersensitivity to any compound or excipient of the Eyebon Eye Wash 2. have had the presence of any ocular condition that could affect the patient's safety or study parameters (narrow angle glaucoma requiring medication or laser treatment, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye). 3. have had a known history of vernal keratoconjunctivitis and/or atopic eratoconjunctivitis; 4. have had an ocular surgical intervention within 3 months prior to study and/or a history of refractive surgery within 6 months prior to study. 5. have had any presence of active ocular infection (bacterial, viral, or fungal) or preauricular lymphadenopathy, or positive history of an ocular herpetic infection at their visits. 6. have had any uncontrolled systemic disease. 7. have had a history of status asthmaticus, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to study allergens. 8. have manifested signs or symptoms of clinically active allergic conjunctivitis (defined as the presence of any itching or >1 hyperemia in the conjunctival vessel bed) in either eye at the start visit. 9. be a female who was currently pregnant, nursing, or planning a pregnancy. 10. have used any of the disallowed medications (topical, topical ophthalmic, systemic and/or injectable) during the period indicated before and during the study period, including *aspirin, aspirin containing products *H1-antagonist antihistamines (including ocular) and all other anti-allergy therapies including prescription, over-the-counter, homeopathy agents *all other topical ophthalmic preparations (including tear substitutes) other than study drops *corticosteroids or mast cell stabilizers *depot corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation points Baseline (10 minutes post qualifying CAC test) and at 1, 5, 10, 15, 20, 30, 45 and 60 minutes after eye washing. 2. Contents of the evaluation(Effectiveness) (1) Ocular itching (2) Conjunctival redness (3) Eyelid swelling (4) Chemosis (5) Overall Satisfaction 3. Score (1) Ocular itching: 0-4 (2) Conjunctival redness: 0-4 (3) Eyelid swelling: 0-3 (4) Chemosis: 0-4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation points Baseline (10 minutes post qualifying CAC test) and at 1, 5, 10, 15, 20, 30, 45 and 60 minutes after eye washing. 2. Contents of the evaluation(Safety) (1)Blood pressure (2)Pulse measurement (3)Visual acuity test (4)Anterior ocular segment and fundus | — |
Countries
Japan
Contacts
Public ContactHiroshi Fujishima
Tsurumi University Faculty of Dentistry
Outcome results
None listed