Diabetes Mellitus, Dry Eye Syndromes
Conditions
Keywords
dry eye syndromes, diabetes mellitus
Brief summary
A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium Hyaluronate in the treatment of Dry Eye of diabetic patients.
Interventions
DRUG0.3% Sodium Hyaluronate
five times per day for the intervention of eye drop
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. medical history of diabetes 2. diagnosed with proliferative diabetic retinopathy 3. diagnosed with dry eye 4. not involvement in other drug experiment in the past 2 weeks 5. vision acuity better than 0.1 6. no local drug using history or with at least 2 weeks blanking period
Exclusion criteria
1. allergy to any of the drug ingredient 2. being or going to be pregnant or in lactation period 3. with any other eye disease or other serious disease which might affect the trial or could not get in follow-up 4. with any eye surgery history in the past six months 5. usage of hormone for replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ocular surface disease index | up to 2 months | pre-,1,4,8 weeks after the initiation of the study(the use of drug for experimental group) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tear break up time | up to 2 months | BUT |
| Schirmer' test | up to 2 months | test of tear secretion |
| conjunctival goblet cells density | up to 2 months | indirect assessment of tear quality |
| corneal fluorescein staining assessment | up to 2 months | assessment of the corneal invasion |
Countries
China
Contacts
Primary ContactZhang Xiulan, M.D.
Outcome results
None listed