Dry eye disease
Conditions
Interventions
The TRTR group:Cycle 1 test formulation (T), cycle 2 reference formulation (R), cycle 3 test formulation (T), cycle 4 reference formulation (R)
The RTRT group:Cycle 1 reference formulation (R), cycle 2 test formulation (T), cycle 3 reference formulation (R), cycle 4 test formulation (T)
Sponsors
Chengdu Xinhua Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age and Gender: Healthy male or female subjects aged 18-65 years (inclusive of 18 and 65 years); 2.Weight Criteria: Male weight >=50.0 kg, female weight >= 45.0 kg, Body Mass Index (BMI) between 18.0 and 28.0 kg/m^2; 3.No abnormalities or clinically insignificant abnormalities observed in intraocular pressure, fundus examination, and slit-lamp examination; 4. In a non-anesthetized state, Schirmer I test measurement of tear strip wetting length > 10mm within 5 minutes; 5. Willing to sign an informed consent form and have a thorough understanding of the study content, procedures, and potential adverse reactions; 6.Subjects are able to communicate well with the investigator and understand and comply with the various requirements of this study.
Exclusion criteria
Exclusion criteria: The presence of any of the following conditions will result in exclusion from the study: 1.(Screening Period/Admission Interview) Presence of any clinically significant ocular/systemic disease, as determined by the investigator, including but not limited to Stevens-Johnson syndrome, conjunctival scarring, cardiovascular system, endocrine system, digestive system, urinary system, hematologic system, nervous system, immune system, metabolic disorders, and a history of major diseases such as malignant tumors, or mental illness or other diseases that the investigator deems unsuitable for participation in the clinical trial; 2.(Screening Period/Admission Interview) History of or current ocular diseases such as infection or trauma in either eye within one month prior to the first dose; 3.(Screening Period/Admission Interview) Any history of eye surgery (including laser refractive surgery) or monocular vision; Any eye has received other eye surgeries or treatments (including eyelid surgery, laser treatment, and meibomian gland probing, etc.) within 3 months before screening or plans to undergo any eye surgery during the study period; 4.(Screening Period/Admission Interview) Wearing contact lenses or colored contact lenses in either eye within 7 days prior to the first dose and/or requiring to wear them throughout the entire trial period; 5.(Screening Period/Admission Interview) Use of any topical ophthalmic products (e.g., traditional Chinese medicine eye drops, antibiotic eye drops, recombinant monoclonal antibody eye drops, or ophthalmic gels, etc.) within 1 month prior to the first dose; 6.(Screening Period/Admission Interview) Use of any medication (including any prescription drugs, over-the-counter drugs, traditional Chinese medicine or health supplements, artificial tears) within 14 days prior to the first dose; 7.(Screening Period/Admission Interview) Known allergy or hypersensitivity to the study drug or its components, or a history of severe multiple allergies and/or severe allergies (including ocular allergies), or allergic constitution: such as allergies to two or more drugs or foods; 8.(Screening Period/Admission Interview) Blood donation (including apheresis) or significant blood loss (>=400mL), receipt of blood transfusions or blood products within 3 months prior to the first dose, or plans to donate blood or blood components during the trial period; 9.(Screening Period/Admission Interview) Vaccination within 1 month prior to the first dose, or plans to receive vaccinations during the trial period; 10.(Screening Period/Admission Interview) History of drug abuse, drug dependence, or drug use within 1 year prior to screening; 11.(Screening Period/Admission Interview) Average daily smoking amount greater than 5 cigarettes within 3 months prior to screening, or inability to stop using any tobacco products throughout the entire trial period; 12.(Screening Period/Admission Interview) Weekly alcohol consumption greater than 14 units within 3 months prior to screening (1 standard unit contains 17.5ml or 14g of pure alcohol, the alcohol content of different types of alcoholic beverages is indicated by volume ratio, and the daily alcohol consumption is equivalent to 70ml of 50° liquor or 700ml of 5° beer), or inability to abstain from alcohol throughout the entire trial period; 13.(Screening Period/Admission Interview) Excessive consumption of tea, coffee, and/or caffeinated beverages daily within 3 months prior to screening (averaging mor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Concentration(Cmax) of Lifitegrast in tears;Area under the concentration time-curves from time zero to last time of quantifiable concentration(AUC0-t) of Lifitegrast in tears; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum concentration (Tmax)of Lifitegrast in tears;Area Under Curve from Time zero(AUC0-8) to Infinity of Lifitegrast in tears;Elimination rate constant(?z) of Lifitegrast in tears;Elimination half life(t1/2) of Lifitegrast in tears;Area Under the Curve Extrapolated( AUC_%Extrap_obs) of Lifitegrast in tears;Maximum Concentration(Cmax) of Lifitegrast in plasma;Area under the concentration time-curves from time zero to last time of quantifiable concentration(AUC0-t) of Lifitegrast in plasma;Time to maximum concentration (Tmax)of Lifitegrast in plasma;Area Under Curve from Time zero(AUC0-8) to Infinity of Lifitegrast in plasma;Elimination rate constant(?z) of Lifitegrast in plasma;Elimination half life(t1/2) of Lifitegrast in plasma;Area Under the Curve Extrapolated( AUC_%Extrap_obs) of Lifitegrast in plasma;Safety evaluation: vital signs;Safety evaluation: blood routine test;Safety evaluation: urine routine;Safety evaluation: blood pregnancy;Safety evaluation: 12-lead electrocardiogram;Safety evaluation: Physical examination;Safety evaluation: ophthalmologic examination;Safety evaluation: adverse events;Safety evaluation: serious adverse events; | — |
Countries
China
Contacts
Public ContactXiaolan Yong
Chengdu Xinhua Hospital
Outcome results
None listed