seasonal allergic conjunctivitis
Conditions
Interventions
Treatment group: Alrex (0.2% Lotemax)
Control:Patalo (0.1% olopatadine hydrochloride)
Sponsors
Eye, Ear, Nose, and Throat Hospital, Shanghai Medical College, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This study enrolled subjects who met the following criteria: 1. Subjects must reach the legal age (at least 18 years) at the time of signing the informed consent and have the ability to provide voluntary informed consent; 2. The subject must be able to understand and provide written consent to the informed consent form (ICF) as approved by the Ethics Committee (IRB / EC); 3. Subjects diagnosed with acute SAC must be allergic to each other at the first follow-up, with no individual eye pruritus score of 4 or less, and bulbar conjunctival hyperemia (eye-redness) score of 2 or more; 4. Any gender, female subjects should be non-childbearing women or women of childbearing age negative for pregnancy test; 5. Able to and willing to follow all treatment and follow-up / study subjects.
Exclusion criteria
Exclusion criteria: This study will exclude subjects who meet the following criteria: 1. The subject participates in any other drug or medical device clinical study within 30 days before enrollment and / or during the study; 2. Active subjects who did not belong to the following situations: (1) Menopausal women; (2) Have done sterilization surgery; (3) Always use one of the following contraceptives during the study; (4) IUD; (5) barrier method (condom or diaphragm) plus spermicide (> 14 days); (6) Hormonal contraception (same dose and same formula for at least 6 months); 3. lactating women; 4. Subjects known to be allergic to or disabling ophthalmic corticosteroid medications to the study drug or its components (including benzalkonium chloride); 5. Use the following drugs that are not permitted within the designated timeframe prior to the first visit or during the study: (1) H1 partial histamine or histamine receptor antagonist, combined with H1 histamine blockers and vasoconstrictor drugs, within 7 days prior to the first visit; (2) Use decongestant drugs within 7 days prior to the first visit; (3) Use of monoamine oxidase inhibitors within 7 days prior to the first visit; (4) Use all other ocular topical medications within 7 days prior to the first visit; (5) Prostaglandin or prostaglandin derivatives (NSAIDs) were used within 7 days prior to the first visit; (6) Inhalation, ophthalmic or topical use of hormones or mast cell stabilizers within 14 days prior to the first visit; (7) Use long-acting corticosteroids 45 days prior to first visit; (8) Immunosuppressants are used within 2 months prior to the first visit; 6. Any abnormalities in the subject lead to unreliable non-contact IOP measurements; 7. Ocular pressure in any one eye greater than 21mmHg or all types of glaucoma patients; 8. The best corrected visual acuity (eyepia scale decimal visual acuity) in any one eye is less than or equal to 0.5; 9. Any serious eye disease or other disease history (including generalized allergic diseases such as asthma or rhinitis) affects the subject to complete the test, or affect the subject's safety or test parameters; 10. Subjects who can not follow the protocol (eg, delirious, debilitated, alcohol and substance abuse); 11. Can not or do not want to stop wearing contact lenses during the study subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conjunctival hyperemia; | — |
Countries
China
Contacts
Public ContactGong Lan
Eye, Ear, Nose, and Throat Hospital, Shanghai Medical College, Fudan University
Outcome results
None listed