dry eye
Conditions
Interventions
:0.1% sodium bromide hydrate eye drops + 0.1 sodium hyaluronate ophthalmic solution, 28 days
:0.1% Pranoprofen eye drops + 0.1 sodium hyaluronate ophthalmic solution, 28 days
:0.02% Fluorometholone eye drops + 0.1 sodium hyaluronate ophthalmic solution, 28 days
Control group:0.1 sodium hyaluronate ophthalmic solution, 28 days
Sponsors
Eye Institute of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in this clinical study, andsigned informed consent. 2. Sex is not limited, age 18 ~ 70 years of age. 3. Clinical signs andsymptoms of dry eye,clinical examination in accordance with the "dry eye expert consensus" diagnostic criteria (as follows): (1) There is dryness, foreign body sensation, burning sensation, fatigue, discomfort, visual fluctuation of subjective symptoms andBUT of less than 5 seconds or Schirmer I test (without surface anesthesia) less than 5mm/5min; (2) There is dryness, foreign body sensation, burning sensation, fatigue, discomfort, visual fluctuation of subjective symptoms andBUT between 5 to 10s or 5 < Schirmer I test (without surface anesthesia) <=10mm/5min. At the same time with conjunctival andcorneal fluorescein staining; 4. Corneal fluorescein staining of 0-I class andconjunctival fluorescein staining 0-III grade; 5. the choice of study eyes: If patients were treated with both eyes, the eye of the patient with high symptom score was studied; Such as the equal score, the corneal fluorescein staining more serious eye were studied; Such as the degree of the same eyes fluorescein staining, the right eye for the study; 6. The trial was not in clinical trials within 2 weeks; 7. Other medications are not being used, or other drugs are being used but it has been discontinued for more than 2 weeks.
Exclusion criteria
Exclusion criteria: 1. Any component of the test drug allergy; 2. Pregnant or lactating women or recent fertility planners; 3. Clinical diagnosis of fungal, bacterial or viral angle, conjunctivitis active stage; 4. The other conjunctiva, cornea andiris were significantly associated with the disease; 5. Break-up time = 0 seconds, or Schirmer test < 2 mm /5 minutes; 6. Patients with severe MGD (grade 4); 7. Combined with severe heart, cerebral blood vessel, liver, kidney andhematopoietic system, andother serious diseases; 8. In the last six months, there are internal ocular surgery or ocular trauma; 9. Hormone replacement therapy for postmenopausal women; 10. Acceptting the treatment of lacrimal point embolism in the last 1 months; 11. Patients with HSK infection; 12. Treatment may affect the results (such as systemic steroid, immunosuppressive therapy); 13. During the experiment, the contact lens was not stopped; 14. Patients with systemic or ocular long-term use may affect research andevaluation; 15. During the trial period, the drug was not guaranteed andfollowed up; 16. S Sjoren syndrome, systemic disease, andother ocular diseases that affect efficacy; 17. The researchers considered that there was no reason for the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tear meniscus height;TBUT;Schirmer Test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal staining scores;Conjunctival staining scores; | — |
Countries
China
Contacts
Public ContactZuguo Liu
Outcome results
None listed