Clinical trial NCT04775303: A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Moderate to Severe Dry Eye
Keywords: Dry eye
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cornea staining score (NEI scale)
timeFrame: 12 weeks
Secondary outcomes:
measure: Ratio of patients who have improvement, deterioration, and no-change of cornea staining scores(NEI scale)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Conjunctival staining scores (NEI scale)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Tear Break-Up Time (TBUT)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: SANDE(Symptom Assessment in Dry Eye) score
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Tear Meniscometry score
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: ODS (Ocular Discomfort Scale)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Patient Reported Outcome (PRO)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Kyoung Yul Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: