A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Dry Eye
• Intervention / Treatment: Drug: Cyclosporine 0.1% (Ikervis®) 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kyoung Yul Seo, MD, PhD; Phone Number: 82-2-2228-3570; Email: SEOKY@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
    • Contact: Kyoung Yul Seo; Phone Number: 82-2-2228-3570; Email: SEOKY@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 weeks, 8 weeks, 12 weeks
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.	4 weeks, 8 weeks, 12 weeks
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.	4 weeks, 8 weeks, 12 weeks
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	4 weeks, 8 weeks, 12 weeks
Tear Meniscometry score	A simple method of quantification of the volume of tear meniscus in the diagnosis of the dry eye syndromes.	4 weeks, 8 weeks, 12 weeks
ODS (Ocular Discomfort Scale)	A simple questionnaire to evaluation the dry eye symptom of stinging, irritation, itching, and blurred vision.(0 to 10 points)	4 weeks, 8 weeks, 12 weeks
Patient Reported Outcome (PRO)	A short questionnaire to evaluation the improvement of dry eye symptom by a patient.	12 weeks

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Kyoung Yul Seo, MD, PhD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Dry eye
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: 4-2019-1156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No