Dry Eye Syndrome (DES)
Conditions
Keywords
Dry eye syndrome
Brief summary
This study aims to evaluate the therapeutic efficacy and safety of investigational product compared with placebo in adult patients with dry eye disease. Patients will receive investigational product or placebo for 3 months, and the therapeutic effect will be assessed based on the change in corneal staining score from baseline.
Interventions
DRUGTJO-087
one drop in each eye, twice daily (1 drop of IP, 1 drop of placebo)
one drop in each eye, twice daily (2 dose of placebo)
Sponsors
Taejoon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥20 years (male or female) * Patients with dry eye symptoms * Fluorescein corneal staining score(NEI scale) ≥4 * Schirmer test result (without anesthesia) ≤10 mm/5 min in * Tear film break-up time (TBUT) \<10 seconds
Exclusion criteria
* Presence or history of systemic or ocular disorder or condition that could affect the interpretation of study results * Intraocular pressure (IOP) \>21 mmHg * Planned use of contact lenses during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corneal Staining Score at 12 weeks | Week 12 | Change from Baseline in corneal staining using blue fluorescein staining procedure at 12 weeks. |
Countries
South Korea
Outcome results
None listed