Dry Eye
Conditions
Brief summary
Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.
Interventions
DRUGdiquafosol ophthalmic solution
DE-089 topical ocular application, 6 times daily for 4 weeks.
DRUG0.1% sodium hyaluronate ophthalmic solution.
0.1% HA topical ocular application, 6 times daily for 4 weeks.
Sponsors
Santen Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Those who show: * Keratoconjunctival disorder confirmed with vital dye staining * Abnormal Schirmer score results
Exclusion criteria
* Eye disease that needs therapy other than that for dry eye * Those who need to wear contact lenses during the clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the fluorescein and rose bengal staining score | 2 weeks and 4 weeks from baseline. | 1. Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority) 2. Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in tear film breakup time (second) | 2 weeks and 4 weeks from baseline. | Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation |
Countries
China, Singapore
Outcome results
None listed