Dry Eye Disease (DED)
Conditions
Brief summary
This study compares the immediate therapeutic and mucin-secreting effects 30 minutes after instillation of 3% diquafosol and 2% rebamipide in dry eye disease.
Interventions
DRUG3% diquafosol (right eye) and 2% rebamipide (left eye)
3% diquafosol was instilled in the right eye and 2% rebamipide in the left eye.
DRUG2% rebamipide (right eye) and 3% diquafosol (left eye)
2% rebamipide was instilled in the right eye and 3% diquafosol in the left eye.
Sponsors
Kukje Pharma
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is a paired-eye design study, where patients received 3% diquafosol in one eye and 2% rebamipide in the contralateral eye.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients 19 years or older * complaint of at least one dry eye symmptom and tear breakup time \< 7 seconds
Exclusion criteria
* Sjogren's syndrome * prescription history of systemic steroids or immunosuppressants * prior ocular surgery within six months of enrollment * treatment with diquafosol or rebamipide eye drops within 2 weeks of enrollment * treatment with punctal plug within 1 month of enrollment * intraocular pressure exceeding 25mmHg * usage of contact lens during the study * active ocular infection * pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| corneal sensitivity (esthesiometer) | Before instillation of eyedrops, and 30 minutes after instillation of eyedrops | Unit: mm |
| tear meniscus height (TMH) | Before instillation of eyedrops, and 30 minutes after instillation of eyedrops | Unit: mm |
| lipid layer thickenss (LLT) | Before instillation of eyedrops, and 30 minutes after instillation of eyedrops | Unit: nm |
| visual analog scale (VAS) score | Before instillation of eyedrops, and 30 minutes after instillation of eyedrops | Unit: points |
| tear breakup time (TBUT) | Before instillation of eyedrops, and 30 minutes after instillation of eyedrops | Unit: Seconds |
| ocular staining score (OSS) | Before instillation of eyedrops, and 30 minutes after instillation of eyedrops | National Eye Institute Scale, 0-15 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tear MUC5AC concentration | Before instillation of eyedrops, and 30 minutes after instillation of eyedrops | measured using enzyme-linked immunosorbent assay (ELISA) |
| tear MUC1 concentration | Before instillation of eyedrops, and 30 minutes after instillation of eyedrops | measured using enzyme-linked immunosorbent assay (ELISA) |
Countries
South Korea
Outcome results
None listed