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

NCT04775303 | Unknown Phase 4

• 1 other identifier: 4-2019-1156
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Dry Eye

Keywords

Dry eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Ratio of patients who have improvement, deterioration, and no-change of cornea staining scores(NEI scale)

  4 weeks, 8 weeks, 12 weeks

• Conjunctival staining scores (NEI scale)

  4 weeks, 8 weeks, 12 weeks

• Tear Break-Up Time (TBUT)

  4 weeks, 8 weeks, 12 weeks

• SANDE(Symptom Assessment in Dry Eye) score

  4 weeks, 8 weeks, 12 weeks

• Tear Meniscometry score

  4 weeks, 8 weeks, 12 weeks

Study Arms (1)

experimental group

EXPERIMENTAL

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

Drug: Cyclosporine 0.1% (Ikervis®) eye drop

Interventions

Cyclosporine 0.1% (Ikervis®) eye drop DRUG

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

experimental group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Kyoung Yul Seo, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyoung Yul Seo, MD, PhD

CONTACT

82-2-2228-3570; SEOKY@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: September 25, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)