Moderate to Severe Dry Eye
Conditions
Keywords
Dry eye
Brief summary
A clinical trial to evaluate the efficacy and safety of Cyclosporine 0.1% (Ikervis®) for moderate to severe dry eye patients who changed to Cyclosporine 0.1% eye drop(Ikervis®) due to lack of treatment effects of the previous Cyclosporine 0.05% eye drop.
Detailed description
Eligible patients who agree to participate in the clinical trial in writing will be administered Cyclosporine 0.1% eye drop(Ikervis®) one drop once daily for 12 weeks. Efficacy and safety will be evaluated at baseline, 4 weeks, 8 weeks, and 12 weeks.
Interventions
DRUGCyclosporine 0.1% (Ikervis®) eye drop
One drop of Cyclosporine 0.1% (Ikervis®) eye drop once daily for 12 weeks
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 19 and less than 80 years old 2. A patient with moderate or severe dry eye who has used Cyclosporine 0.05% eye drop for more than 3 months and has no or insufficient treatment effect \- No or insufficient treatment effect should meet the following criteria through tests used to diagnose dry eyes * A SANDE (Symptom Assessment in Dry Eye) score of 40 or more on the severity and frequency of dry eye symptoms. * Cornea staining score (NEI scale) 3 or more points * Tear Break Up Time(TBUT) 10 seconds or less * Tear volume tested by Tear Meniscometry less than 5mm * Has One or more of the dry eye symptoms; stinging, irritating, itching or blurred vision. * Use of diquafosol tetrasodium 3% eye drop and/or artificial tears are allowed with no change of products and dosage throughout the trial period 3. A person who voluntarily agrees in writing to participate in this clinical trial
Exclusion criteria
1. Use of eye drops within four weeks of the consent date such as steroids, glaucoma, allergies and anti-inflammatory drugs, etc. 2. Systematic steroid within four weeks of the consent date 3. Patients with pterygium 4. Start new immunosuppressive drugs or change in dosage that can affect immune function within four weeks of the consent date due to an unregulated systemic disease. 5. Severe MGD patient 6. Ophthalmic surgery (including Lasik/Lasek) and trauma in eyes within the last three months 7. Wearing contact lenses during a clinical trial period 8. Planning an eye surgery (including Lasik/Lasek) during the clinical trial period 9. Hypersensitivity to the clinical trial drug 10. Active or suspected eye infections 11. Pregnant or breastfeeding, or women planning to become pregnant 12. Participation in other clinical trials within three months 13. Any person who is deemed unfit for clinical trial by a investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cornea staining score (NEI scale) | 12 weeks | The cornea staining score(NEI scale) is a grading scale for the corneal surface after fluorescein staining to help measure the efficacy of dry eye treatment. A standardized grading system of 0 to 3 is used for each of the five areas on each cornea. Grade 0 is specified when no staining is present, and the maximum score is 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of patients who have improvement, deterioration, and no-change of cornea staining scores(NEI scale) | 4 weeks, 8 weeks, 12 weeks | Cornea staining scores (NEI scale) (Improvement: decrease by more than one point / Deterioration : increase by more than one point / No change: no change in score) |
| Tear Break-Up Time (TBUT) | 4 weeks, 8 weeks, 12 weeks | Tear Break-Up Time(TBUT) is a clinical test used to evaluate the dry eye disease after the fluorescein is instilled into the patient's tear film. |
| SANDE(Symptom Assessment in Dry Eye) score | 4 weeks, 8 weeks, 12 weeks | SANDE (Symptom Assessment in Dry Eye)is a short questionnaire that quantifies both severity and frequency of dry eye symptoms |
| Conjunctival staining scores (NEI scale) | 4 weeks, 8 weeks, 12 weeks | The conjunctival staining score(NEI scale) is a grading scale for the conjunctival surface after fluorescein staining to help measure the efficacy of dry eye treatment. A standardized grading system of 0 to 3 is used for each of the six areas on each conjunctiva. Grade 0 is specified when no staining is present, and the maximum score is 18. |
| ODS (Ocular Discomfort Scale) | 4 weeks, 8 weeks, 12 weeks | A simple questionnaire to evaluation the dry eye symptom of stinging, irritation, itching, and blurred vision.(0 to 10 points) |
| Patient Reported Outcome (PRO) | 12 weeks | A short questionnaire to evaluation the improvement of dry eye symptom by a patient. |
| Tear Meniscometry score | 4 weeks, 8 weeks, 12 weeks | A simple method of quantification of the volume of tear meniscus in the diagnosis of the dry eye syndromes. |
Countries
South Korea
Contacts
Primary ContactKyoung Yul Seo, MD, PhD
Outcome results
None listed