Dry eye
Conditions
Interventions
Group A:Both upper and lower punctal occlusion
Group B: lower punctal occlusion
Group C:upper punctal occlusion
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 withdrawed 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 |
|---|---|
| Total score of ocular surface disease index ;Schirmer I test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tear break-up time;Corneal fluorescein staining;Lissamine green staining;Tear meniscus height;Tear meniscus depth;Tear meniscus area;Frequency of artificial tears usage; | — |
Countries
China
Contacts
Public ContactLan Gong
Outcome results
None listed