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

Moderate to Severe Dry Eye Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775303
• Other study ID #: 4-2019-1156
• Status: Recruiting
• Phase: Phase 4
• Start date: September 25, 2020
• Est. completion date: January 2022

Study information

• Verified date: February 2021
• Source: Yonsei University
• Contact: Kyoung Yul Seo, MD, PhD
• Phone: 82-2-2228-3570
• Email: SEOKY[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Moderate to Severe Dry Eye

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Reported Outcome (PRO)	A short questionnaire to evaluation the improvement of dry eye symptom by a patient.	12 weeks