Dry eye
Conditions
Interventions
Group A:0.02ml HBC injection
Group B:0.04ml HBC injection
Group C:punctal occlusion with VisiPlug
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participated in this clinical study and signed an informed consent; 2. Male or female, aged 18 to 70 years old; 3. Patients with dry eye signs and symptoms, consistent with either criterion as follows: (1) Criterion 1: Patients with at least one positive symptom, such as dry eye, foreign body sensation, burning sensation, eye fatigue,eye distension, vision fluctuation; And tear film break-up time equal to or less than 5 seconds, or Schirmer test (without anesthetic) equal to or less than 5 mm/5 minutes; (2) Criterion 2: Patients with at least one positive symptom, such as dry eye, foreign body sensation, burning sensation, eye fatigue, eye distension, vision fluctuation; And tear film break-up time equal to or less than 10 seconds and longer than 5 seconds, or Schirmer test (without anesthetic) equal to or less than 10 mm/5 minutes and longer than 5 mm/5 minutes; And patients should show positive corneal fluorescein staining; 4. welling to follow the requirements of this study; 5. Subjects did not participate in other clinical trials during the last four weeks; 6. Subjects did not use any topical medications other than artifical tears, or have used these medications, but withdraw them more than two weeks before; 7. The daily life vision of included subjects eye should be equal to or more than 0.1.
Exclusion criteria
Exclusion criteria: 1. subjects with inflammation and infection in lacrimal systerm; 2. subjects with nasolacrimal duct blocking or stenosis; 3. subjects with severe conjunctivochalasis; 4. Allergy to any ingredient of the test materials; 5. Clinically diagnosed as fungal, bacterial or viral keratitis/conjunctivitis in active stage; 6. Co-existence with other conjunctiva, cornea and iris lesions; 7. Patients with severe primary disease such as severe heart, brain and blood vessels, liver, kidney and hematopoietic systems disease; 8. Patients who received intraocular surgery or with intraocular trauma in the last six months; 9. Postmenopausal women with hormone replacement therapy; 10. Patients received permanent punctal occlusion or absorbable punctal occlusion in the last six months; 11. Patients who cannot stop wearing contact lenses during the trial; 12. Patients who cannot obey the required treatments and follow-ups during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schirmer I test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total score of ocular surface disease index;Corneal fluorescein staining;Tear meniscus height;Frequency of artificial tears usage;Tear break-up time; | — |
Countries
China
Contacts
Public ContactGong Lan
Eye & ENT Hospital of Fudan University
Outcome results
None listed