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

NCT ID: NCT04775303

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2022-01-31

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.

Conditions

Moderate to Severe Dry Eye

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Cyclosporine 0.1% (Ikervis®) eye drop - one drop once daily

Group Type: EXPERIMENTAL

Cyclosporine 0.1% (Ikervis®) eye drop

Intervention Type: DRUG

One drop of Cyclosporine 0.1% (Ikervis®) eye drop once daily for 12 weeks

Interventions

Cyclosporine 0.1% (Ikervis®) eye drop

One drop of Cyclosporine 0.1% (Ikervis®) eye drop once daily for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyoung Yul Seo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Kyoung Yul Seo, MD, PhD

Role: CONTACT

SEOKY@yuhs.ac

82-2-2228-3570

Facility Contacts

Kyoung Yul Seo

Role: primary

SEOKY@yuhs.ac

82-2-2228-3570

Other Identifiers

4-2019-1156

Identifier Type: -

Identifier Source: org_study_id