A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: experimental group Cyclosporine 0.1% (Ikervis®) eye drop - one drop once daily |
Drug: Cyclosporine 0.1% (Ikervis®) eye drop
One drop of Cyclosporine 0.1% (Ikervis®) eye drop once daily for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
- 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.
- 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
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 19 and less than 80 years old
-
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
- A person who voluntarily agrees in writing to participate in this clinical trial
Exclusion Criteria:
-
Use of eye drops within four weeks of the consent date such as steroids, glaucoma, allergies and anti-inflammatory drugs, etc.
-
Systematic steroid within four weeks of the consent date
-
Patients with pterygium
-
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.
-
Severe MGD patient
-
Ophthalmic surgery (including Lasik/Lasek) and trauma in eyes within the last three months
-
Wearing contact lenses during a clinical trial period
-
Planning an eye surgery (including Lasik/Lasek) during the clinical trial period
-
Hypersensitivity to the clinical trial drug
-
Active or suspected eye infections
-
Pregnant or breastfeeding, or women planning to become pregnant
-
Participation in other clinical trials within three months
-
Any person who is deemed unfit for clinical trial by a investigator
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Severance Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yonsei University
Investigators
- Principal Investigator: Kyoung Yul Seo, MD, PhD, Severance Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4-2019-1156