Allergic conjunctivitis / postoperative anti-inflammatory
Conditions
Interventions
Group 1:0.05% test drug or placebo, 1 drop, 1 time
Group 2:0.1%Study drug or placebo, 1 drops, 1 time
Group 3:0.2%Study drug or placebo, 1 drops, 1 time
Group 4:0.3%Study drug or placebo, 1 drops, 1 time
Group 5:0.4%Study drug or placebo, 1 drops, 1 time
Group 6:0.2%Study drug or placebo, 1 drops / time, 4 times / day for 7 consecutive days
Group 7:0.3%Study drug or placebo, 1 drops / time, 4 times / day for 7 consecutive days
Group 8:0.4%Study drug or placebo, 1 drops / time, 4 times / day for 7 consecutive days
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18-45 years (including 18 and 45 years); 2. Weight: male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, and body mass index [BMI = weight (kg) / height 2 (M2)] is in the range of 19.0 ~ 26.0 kg / m2 (including critical value); 3. The corrected visual acuity of both eyes shall be >= 1.0, and the ophthalmic examination (including intraocular pressure, color fundus photography, standard ophthalmic examination and corneal fluorescence staining) is normal or abnormal, without clinical significance; 4. Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of inner eye surgery or laser surgery in the past; 2. Subjects who have worn contact lenses or color lenses within 2 weeks before screening, or those who need to wear contact lenses during the test; 3. Those who have used any drugs, including ophthalmic drugs, within 2 weeks before screening; 4. Those who currently suffer from diseases of the central nervous system, mental, cardiovascular, kidney, liver, respiratory, metabolic and skeletal muscles; 5. Physical examination, vital signs, electrocardiogram, and laboratory tests judged by researchers to have clinically significant abnormalities; 6. Those who currently suffer from gastrointestinal diseases, including gastrointestinal bleeding, ulcers, perforation and other diseases; 7. Those with positive results of infectious disease screening [hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody and human immunodeficiency virus (HIV) antibody]; 8. Patients with a clinically significant history of allergic reaction, especially a history of drug allergy, or known allergy to the components or active metabolites of this drug; 9. Those who smoked more than 5 cigarettes on average per day in the 3 months before screening, or those who could not give up smoking 48 hours before drug administration until they were out of the group; 10. The average daily alcohol intake in the 3 months prior to screening exceeds 2 units (1 unit = 10 mL of ethanol, i.e. 1 unit = 200 mL of beer with 5% alcohol content or 25 mL of spirits with 40% alcohol content or 85 mL of wine with an alcohol content of 12%), or those who cannot give up drinking 48 hours before the administration until they leave the group, or those who have a positive alcohol breath test; 11. Those with a history of drug abuse 1 year before screening, or positive drug abuse screening [ketamine, morphine, methamphetamine, MDMA, tetrahydrocannabinol acid, cocaine] ; 12. Those who have participated in clinical trials within 3 months before screening; 13. Those who donated blood or lost more than 400 mL of blood within 3 months before screening (except for female menstrual blood loss); 14. Those who have a history of dizziness with acupuncture or dizziness or difficulty in venous blood collection; 15. Those who have special requirements for diet cannot abide by the provided diet and corresponding regulations, and cannot avoid eating xanthine/caffeine-containing beverages (coffee, tea, cola, etc.) or food (animals) 48 hours before administration until they leave the group. liver, chocolate, etc.), or those who eat fruits or juices (grapefruit, grapefruit, mango, etc.) that may affect metabolism; 16. Females of childbearing age have a positive pregnancy test, or the subjects (including male subjects) have a reproductive plan during the test period to 3 months after leaving the group and are unwilling to take effective contraceptive measures; 17. Those who do not meet the requirements of the state or Shanghai or Shanghai First People's Hospital for the prevention and control of the new coronavirus epidemic; 18. The investigators think that they are not suitable to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactDing Xueying
Shanghai General Hospital
Outcome results
None listed