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

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04775303
Collaborator
(none)
90
1
1
15.2
5.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cyclosporine 0.1% (Ikervis®) eye drop
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 25, 2020
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cornea staining score (NEI scale) [12 weeks]

    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

  1. Ratio of patients who have improvement, deterioration, and no-change of cornea staining scores(NEI scale) [4 weeks, 8 weeks, 12 weeks]

    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)

  2. Conjunctival staining scores (NEI scale) [4 weeks, 8 weeks, 12 weeks]

    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.

  3. Tear Break-Up Time (TBUT) [4 weeks, 8 weeks, 12 weeks]

    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. SANDE(Symptom Assessment in Dry Eye) score [4 weeks, 8 weeks, 12 weeks]

    SANDE (Symptom Assessment in Dry Eye)is a short questionnaire that quantifies both severity and frequency of dry eye symptoms

  5. Tear Meniscometry score [4 weeks, 8 weeks, 12 weeks]

    A simple method of quantification of the volume of tear meniscus in the diagnosis of the dry eye syndromes.

  6. ODS (Ocular Discomfort Scale) [4 weeks, 8 weeks, 12 weeks]

    A simple questionnaire to evaluation the dry eye symptom of stinging, irritation, itching, and blurred vision.(0 to 10 points)

  7. Patient Reported Outcome (PRO) [12 weeks]

    A short questionnaire to evaluation the improvement of dry eye symptom by a patient.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Severance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Kyoung Yul Seo, MD, PhD, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT04775303
Other Study ID Numbers:
  • 4-2019-1156
First Posted:
Mar 1, 2021
Last Update Posted:
Mar 1, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yonsei University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 1, 2021