Dry Eye, Dry Eye Syndromes
Conditions
Brief summary
In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug. Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.
Interventions
DRUGCyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)
Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two\ six times daily in both eyes
DRUGTJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%
TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes
DRUGTJO-018 (HA 0.15%)
TJO-018 / one drop / 6 times daily in both eyes
Sponsors
Taejoon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A Multicenter, Randomized, Single-blind Study for Evaluating the Efficacy of HA 0.15% Compared with Cyclosporine 0.05% in Moderate to Severe Dry Eye Syndrome
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age 20 or over * Moderate to Severe Dry Eye Disease Patients * Written informed consent to participate in the trial
Exclusion criteria
* Any laser or ocular surgery within 2 months prior screening * Use of contact lenses * Any condition limiting patient's ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corneal Staining Score at Week 12 | Baseline and Week 12 | After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change. * Scale: Oxford grading system that divides into six groups according to severity from 0 (absent) to 5 (severe). * The higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corneal Staining Score at Week 4 and Week 8 | Baseline, Week 4 and Week 8 | After 4, 8 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change. * Scale: Oxford grading system that divides into six groups according to severity from 0 (absent) to 5 (severe). * The higher scores mean a worse outcome. |
Countries
South Korea
Outcome results
None listed