blepharo-keratoconjunctivitis
Conditions
Interventions
treatment group:Zylet (0.5% loteprednol and 0.3% tobramycin ophthalmic suspension)
Control:Tobrdex (0.3% and 0.1% tobramycin dexamethasone ophthalmic suspension)
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will select subjects who meet 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. The subject must be able to self-medicate; 4. At least one eye of the subject was diagnosed with BKC (total score of eye signs and symptoms = 10 points, and at least 1 sign and 1 symptom = 2 points, respectively); 5. Subjects must discontinue wearing contact lenses during the study period; Subjects pinhole eyesight ("E" visual acuity decimal eyesight) = 0.5; 7. Any gender, female subjects should be non-women of childbearing age or urine pregnancy test negative for women of childbearing age; 8. Able to and willing to follow all treatment and follow-up / study subjects.
Exclusion criteria
Exclusion criteria: Exclusion criteria The study will exclude subjects who meet the following criteria: 1. The subject participates in any other drug or clinical study of the medical device within 30 days before enrollment and / or during the study; 2. Sexually active but not severe in the following subjects: (1) Menopausal women; (2) Sterilized surgery; (3) During the study, always use one of the following contraceptive measures; (4) IUD (> 14 days); (5) Barrier (condom or diaphragm) plus spermicide (> 14 days); (6) Hormonal contraception (same dose and same formula for at least 6 months); 3. lactating women; 4. Uncontrolled subjects with systemic or failing diseases such as cardiovascular disease, hypertension, diabetes or cystic fibrosis; 5. Subjects known to be allergic to the study drug or its components (including benzalkonium chloride) or to disable tobramycin or ophthalmic corticosteroid drugs; 6. Subjects who had non-steroidal anti-inflammatory drugs (NSAIDs), analgesics and antihistamines topically or topically in the eye 2 days prior to the first visit and were unable to discontinue the study during the study; 7. Subjects who have used any ocular medications (including artificial tears) within 2 hours prior to Visit 1 and who can not be discontinued during this study; 8. Subjects with systemic or topical ophthalmic use within 72 hours prior to Visit 1 who were not discontinued during the study; 9. Subjects with steroid medications either topically or topically in the 7 days prior to the first visit and who can not be discontinued during the study; 10. Subjects who have had topical or topical ocular mast cell stabilization within 14 days prior to Visit 1 and who can not be discontinued during this study; 11. Subjects who have been immunosuppressed with an immunosuppressant (eg, cyclosporine) either topically or topically in the 30 days prior to the first visit and who can not be discontinued during the study; 12. Subjects suspected of having orbital cellulitis or any other disease that the investigator believes would interfere with the evaluation of drug safety and efficacy; 13. suspected dacryocystitis subjects; 14. Subjects who underwent eye surgery (including laser surgery) at any one eye during the three months prior to screening were included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blepharitis symptoms score; | — |
Countries
China
Contacts
Public ContactGong Lan
Eye, Ear, Nose, and Throat Hospital, Shanghai Medical College, Fudan University
Outcome results
None listed