Glaucoma or high intraocular pressure
Conditions
Interventions
1:0. 00625% test drug or placebo, 1 drop, 1 time
2:0. 0125% test drug or placebo, 1 drop, 1 time
3: 0. 025% test drug or placebo, 1 drop, 1 time
4: 0. 04% test drug or placebo, 1 drop, 1 time
5:0.05% test drug or placebo, 1 drop, 1 time
6:0.0125% test drug or placebo, 1 drop / time, 2 times / day, for 7 consecutive days
7:0.025% test drug or placebo, 1 drop / time, 2 times / day, for 7 consecutive days
8: 0.05% test drug or placebo, 1 drop / time, 2 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) At the time of screening, the age of healthy subjects was 18-45 years old (including the boundary value at both ends), and the gender was not limited; (2) Body mass index (BMI) is 19.0 ~ 26.0 kg / m2 (including the boundary value at both ends); The weight of male subjects is = 50 kg, and that of female subjects is = 45 kg. (3) The corrected visual acuity of both eyes shall be = 1.0, and the ocular symptoms, signs and ophthalmic examinations are normal or abnormal values have no clinical significance; (4) The intraocular pressure (IOP) of both eyes before enrollment was between 14 and 20 mmHg, including the boundary value at both ends. (5) No clinically significant abnormalities were found in the results of vital signs, physical examination, electrocardiogram, laboratory examination (blood routine, blood biochemistry, coagulation function, urine routine) and chest radiograph during the screening period. (6) I have fully understood this study, voluntarily participated and signed the informed consent. (7) The subject shall guarantee and agree to use non drug contraceptive methods (such as condoms or intrauterine devices) with the sexual partners of childbearing age from the date of signing the informed consent form to 30 days after the last administration.
Exclusion criteria
Exclusion criteria: (1) Within one month before the first administration, any eye suffered from ocular diseases such as infection and trauma or other ophthalmic examinations with significant clinical significance [such as intraocular pressure = 21 mmHg, conjunctival congestion grade = 1, corneal fluorescence staining grade = 2], or other patients with chronic or acute ocular diseases (2) Subjects who have worn corneal contact lenses or beautiful pupils within 2 weeks before screening or who need to wear corneal contact lenses or beautiful pupils during the test (3) Previous ophthalmic surgery or ophthalmic laser surgery (4) Pregnant (or positive pregnancy test) lactating women (5) He is suffering from clinically obvious cardiovascular, respiratory, digestive, endocrine, metabolic, neurocutaneous, ophthalmic, infectious and mental diseases or abnormalities (6) Any medications including ophthalmic medications, over-the-counter medications and herbal medicines (except vitamins) were used within 2 weeks before the first administration (7) Previous operations that may affect the results of clinical trials (including but not limited to any cholecystectomy, subtotal gastrectomy, etc., but minor operations such as lipoma resection on the body surface may be excluded) (8) Those who lost blood or donated more than 400 ml of blood within 2 months before participating in the screening of this test (except for female physiological period) (9) Clinically, there is a significant history of allergy, especially a history of drug allergy or known allergy to the components or active metabolites of the drug or the same mechanism of drugs (10) The average alcohol intake in the three months before screening was more than 2 units per day (1 unit = 10 ml ethanol, i.e. 1 unit = 200 ml beer with 5% alcohol or 25 ml spirit with 40% alcohol or 85 ml wine with 12% alcohol) or the drinkers who could not give up drinking or those who were positive in alcohol breath test 48 hours before administration (11) Previous smoking history (average daily smoking volume within 1 month before participating in screening > 5 cigarettes) or disagreed to forbid smoking 48 hours before drug administration until leaving the group (12) Previous drug abuse history or positive drug abuse screening results (13) Participated in other clinical trials within 3 months before participating in this trial screening (14) Subjects who are positive for hepatitis B virus surface antigen, syphilis specific antibody, hepatitis C antibody and AIDS antibody; (15) Patients with a history of needle syncope and blood syncope or difficulty in venous blood collection; (16) Those who have special requirements for diet, who can't follow the diet and corresponding regulations provided, and who can't avoid eating beverages (coffee, tea, cola, etc.) or foods (animal liver, chocolate, etc.) containing xanthine / caffeine 48 hours before the administration until the group is out, or eating fruits or fruit juices (grapefruit, grapefruit, mango, etc.) that may affect metabolism; (17) Those who do not meet the national or Shanghai municipal or Shanghai First People's Hospital novel coronavirus epidemic prevention and control requirements; (18) Any situation that the investigator considers unsuitable for entering this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactDing Xueying
Outcome results
None listed