Back to resultsA Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)
Primary Purpose
Moderate to Severe Dry Eye
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cyclosporine 0.1% (Ikervis®) eye drop
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Dry Eye focused on measuring Dry eye
Eligibility 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
Sites / Locations
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental group
Arm Description
Cyclosporine 0.1% (Ikervis®) eye drop - one drop once daily
Outcomes
Primary Outcome Measures
Cornea staining score (NEI scale)
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)
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)
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)
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
SANDE (Symptom Assessment in Dry Eye)is a short questionnaire that quantifies both severity and frequency of dry eye symptoms
Tear Meniscometry score
A simple method of quantification of the volume of tear meniscus in the diagnosis of the dry eye syndromes.
ODS (Ocular Discomfort Scale)
A simple questionnaire to evaluation the dry eye symptom of stinging, irritation, itching, and blurred vision.(0 to 10 points)
Patient Reported Outcome (PRO)
A short questionnaire to evaluation the improvement of dry eye symptom by a patient.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04775303
Brief Title
A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)
Official Title
An Investigator Initiated Multi-center Phase 4 Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients With Inadequate Effects From Previous Treatment (IKE-03, Switching Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Dry Eye
Keywords
Dry eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Cyclosporine 0.1% (Ikervis®) eye drop - one drop once daily
Intervention Type
Drug
Intervention Name(s)
Cyclosporine 0.1% (Ikervis®) eye drop
Intervention Description
One drop of Cyclosporine 0.1% (Ikervis®) eye drop once daily for 12 weeks
Primary Outcome Measure Information:
Title
Cornea staining score (NEI scale)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Ratio of patients who have improvement, deterioration, and no-change of cornea staining scores(NEI scale)
Description
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)
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Conjunctival staining scores (NEI scale)
Description
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.
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Tear Break-Up Time (TBUT)
Description
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.
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
SANDE(Symptom Assessment in Dry Eye) score
Description
SANDE (Symptom Assessment in Dry Eye)is a short questionnaire that quantifies both severity and frequency of dry eye symptoms
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Tear Meniscometry score
Description
A simple method of quantification of the volume of tear meniscus in the diagnosis of the dry eye syndromes.
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
ODS (Ocular Discomfort Scale)
Description
A simple questionnaire to evaluation the dry eye symptom of stinging, irritation, itching, and blurred vision.(0 to 10 points)
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Patient Reported Outcome (PRO)
Description
A short questionnaire to evaluation the improvement of dry eye symptom by a patient.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyoung Yul Seo, MD, PhD
Phone
82-2-2228-3570
Email
SEOKY@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoung Yul Seo, MD, PhD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyoung Yul Seo
Phone
82-2-2228-3570
Email
SEOKY@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)
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