Moderate to Severe Dry Eye Syndrome
Conditions
Brief summary
This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with topical corticosteroids.
Interventions
DRUGnonsteroid anti-inflammatory drops
nonsteroid anti-inflammatory drops plus artificial tear substitute
DRUGcorticosteroids
corticosteroids plus artificial tear substitute
artificial tear substitute alone
Sponsors
Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* moderate to severe dry eye syndrome * tear film breakup time \>0 second and ≤5 seconds,or schirmer test(no anaesthesia)≥2mm/5min and ≤5mm/5min * corneal staining≥3 scores
Exclusion criteria
* allergic to any composition of the drugs under experiment * previous use of anti-inflammatory drugs or immunosuppressive agent * viral,bacterial or fungal infection of the eye * eyelid anomaly * glaucoma or high IOP * significant meibomian gland dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tear osmolarity | Day 0, Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| corneal staining | 0 day,7th day and 14th day after treatment |
| Schirmer test(without anaesthesia) | 0 day,7th day,14th day after treatment |
| tear film breakup time(TBUT) | 0 day,7th day and 14th day after treatment |
| meibomian gland function | 0 day,7th day and 14th day after treatment |
Countries
China
Outcome results
None listed