Moderate to Severe Dry EyePhase 4NCT04775303
A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)
A Phase 4 study testing Cyclosporine 0.1% (Ikervis®) eye drop in people with Moderate to Severe Dry Eye, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Moderate to Severe Dry Eye
- What is being tested?
- Cyclosporine 0.1% (Ikervis®) eye drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2020to Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul
Kyoung Yul Seo, 82-2-2228-3570, SEOKY@yuhs.ac
About this study
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)
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.
Read the 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
- Being tested
- Cyclosporine 0.1% (Ikervis®) eye drop
- Keywords
- Dry eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine 0.1% (Ikervis®) eye dropDrug
One drop of Cyclosporine 0.1% (Ikervis®) eye drop once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Cyclosporine 0.1% (Ikervis®) eye drop - one drop once daily Receives: Drug: Cyclosporine 0.1% (Ikervis®) eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (7)
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)
Measured: 4 weeks, 8 weeks, 12 weeks
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.
Measured: 4 weeks, 8 weeks, 12 weeks
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.
Measured: 4 weeks, 8 weeks, 12 weeks
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
Measured: 4 weeks, 8 weeks, 12 weeks
Tear Meniscometry score
A simple method of quantification of the volume of tear meniscus in the diagnosis of the dry eye syndromes.
Measured: 4 weeks, 8 weeks, 12 weeks
ODS (Ocular Discomfort Scale)
A simple questionnaire to evaluation the dry eye symptom of stinging, irritation, itching, and blurred vision.(0 to 10 points)
Measured: 4 weeks, 8 weeks, 12 weeks
Patient Reported Outcome (PRO)
A short questionnaire to evaluation the improvement of dry eye symptom by a patient.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start25 Sep 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Dry EyeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyoung Yul Seo, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775303
- Sponsor's protocol ID
- 4-2019-1156
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04775303
- Acronym / sponsor ID
- 4-2019-1156
- Conditions
- Moderate to Severe Dry Eye
- Keywords
- Dry eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Cyclosporine 0.1% (Ikervis®) eye dropCyclosporine 0.1% (Ikervis®) eye drop - one drop once daily |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- A person who voluntarily agrees in writing to participate in this clinical trial
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine 0.1% (Ikervis®) eye dropOne drop of Cyclosporine 0.1% (Ikervis®) eye drop once daily for 12 weeks | Drug | experimental group |
Primary outcome
Cornea staining score (NEI scale)
Time frame: 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.
7 secondary outcomes
Ratio of patients who have improvement, deterioration, and no-change of cornea staining scores(NEI scale)
Time frame: 4 weeks, 8 weeks, 12 weeks
Conjunctival staining scores (NEI scale)
Time frame: 4 weeks, 8 weeks, 12 weeks
Tear Break-Up Time (TBUT)
Time frame: 4 weeks, 8 weeks, 12 weeks
SANDE(Symptom Assessment in Dry Eye) score
Time frame: 4 weeks, 8 weeks, 12 weeks
Tear Meniscometry score
Time frame: 4 weeks, 8 weeks, 12 weeks
ODS (Ocular Discomfort Scale)
Time frame: 4 weeks, 8 weeks, 12 weeks
Patient Reported Outcome (PRO)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoung Yul Seo, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine 0.1% (Ikervis®) eye drop in people with Moderate to Severe Dry Eye, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyoung Yul Seo, MD, PhD (82-2-2228-3570, SEOKY@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cornea staining score (NEI scale) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.