dry eye disease
Conditions
Interventions
experimental group:Astaxanthin from red coccidiococcus was taken orally
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Volunteered to participate in this clinical study and signed the informed consent; 2. Aged 18 to 70 years; 3. Clinical symptoms and signs of dry eye, and clinical examination conforms to one of the diagnostic criteria of "Consensus of Dry Eye Experts" (as follows): (1) have dry feeling, foreign body sensation, burning sensation, subjective symptoms such as fatigue, discomfort, vision fluctuation and BUT one of five seconds or less, or Schirmer I test 5 mm/min or less; (2) have dry feeling, foreign body sensation, burning sensation, one of the subjective symptoms such as fatigue, discomfort, vision fluctuation and 5 < < BUT 10 seconds or less or 5 Schirmer I test (no surface anesthesia) 10 mm / 5 min or less, angular conjunctival fluorescein staining positive at the same time; 4. the corneal fluorescein staining or dotted coloring numbered (and dyeing for 30 points or less) and conjunctival fluorescein staining level 0 - III; 5. Selection of study eye: both eyes of the patients were examined, and the affected eyes with high scores of symptoms and signs were taken as the study eyes; If the scores are equal, the affected eye with heavy corneal fluorescein staining is selected as the study eye; if the degree of fluorescein staining in both eyes is equal, the right eye is selected as the study eye; 6. No clinical trials of other drugs were conducted within 2 weeks. 7. Not taking other drugs to treat dry eye, or not taking other drugs to treat dry eye but have stopped taking drugs for more than 2 weeks.
Exclusion criteria
Exclusion criteria: (1) Allergic to any ingredient in the test drug. (2) Pregnant women or lactating women or recent family planning. (3) Clinically, patients with fungal, bacterial or viral keratitis and conjunctivitis are presumed to be in the active stage. (4) Patients with other obvious lesions of conjunctiva, cornea and iris. (5) Tear film rupture time =0 seconds, or tear secretion test =0 mm /5 minutes. (6) The total corneal staining points are more than 30 points, there are patchy fusion or filamentous objects. (7) Severe MGD patients (grade 4). (8) Complicated with serious heart, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases. (9) Injury of intraocular surgery or extrocular injury within the last 6 months. (10) Hormone replacement therapy for menopausal women. (11) In the past 1 month, he received the treatment of small lacrimal dot embolization. (12) Patients with a history of HSK infection. (13) Treatments that may affect the outcome (e.g., systemic steroids, immunosuppressive therapy). (14) Patients who could not stop wearing contact lenses during the trial. (15) Prolonged systemic or ocular use may affect the study evaluation of patients. (16) There is no guarantee that medication and visitors will be taken as required during the trial. (17) Sjogren's syndrome, systemic diseases, and other ocular diseases that affect the evaluation of efficacy. (16) The investigator considers that there is any reason for not participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSDI; | — |
Countries
China
Contacts
Public ContactLei Tian
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed