Dry EyePhase 4NCT04492878
Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment
A Phase 4 study testing IKERVIS®1mg/mL in people with Dry Eye and Dry Eye Syndromes, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
Trial summary
The proposed study is a prospective, open-label, unicentric, phase IV clinical trial. This study is design to find new efficacy biomarkers for IKERVIS® (1mg/mL ciclosporin) eye drops after 1 and 3 month after initiation of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes, Severe Keratitis
- What is being tested?
- IKERVIS®1mg/mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 4 Feb 2020to 18 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Diagnosis of DED with Severe Keratitis who have not improved despite regular use of tear substitutes by an ophthalmologist, at least 2 months previously.
- Not stable (as defined by the two items below) under at least 2 months of constant and regular use of artificial tears (at least 4 drops a day)
- Fluorescein corneal staining ≥ 2 (Oxford scale) in both eyes.
- DEQ-5 > 6 points
- Use of at least 4 times daily of an ocular artificial tears.
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- Any concomitant medication that may affect DED, ocular surface condition or vision, must have a start date at least 3 months prior to baseline and dosage is not expected to change during the study.
- Best corrected visual acuity (BCVA) of at least 0.1 logMar at 6 meters with each eye.
- Signature of written informed consent form and data protection form.
Who cannot join
- Known allergy or sensitivity to the study product(s) or its components.
- Any ocular pathology other than DED.
- History of severe ocular inflammation other than that due to DED or infection in the 6 previous months to the study inclusion.
- Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution in the 6 previous months or any ocular or systemic surgery or procedure planned during the study duration that may affect the study as assessed by principal investigator.
- History of refractive surgery in the previous 18 months.
- Contact lens use in the ONE previous month to study inclusion and during the duration of the study.
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- Use of any ocular topical medication for pathologies other than DED.
- Use of any other ocular topical medication for DED other than artificial tears during the last ONE (steroids) or THREE months (ciclosporine, tacrolimus) .
- Any uncontrolled severe systemic disease that may affect the eye (except for Sjögren's syndrome)
- The start date of any systemic medication that may affect DED, ocular surface condition or vision is < 3 months prior to baseline or a change in dosage is anticipated during the study.
- Occlusion of the lacrimal puncta either surgically or with plugs within one month prior to study, or anticipated use of the same during the study.
- Pregnancy or breastfeeding.
- Current enrolments in an investigational drug or device study or participation in such a study within 30 day of entry into this study at baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV Open-Label Clinical Trial to Evaluate the Efficacy of Ikervis® on Clinical Parameters and Molecular/Cellular Biomarkers in Dry Eye Patients With Severe Keratitis Who Have Not Improved Despite Regular Use of Tear Substitutes Before and After Exposure to an Adverse Controlled Environment
The proposed study is a prospective, open-label, unicentric, phase IV clinical trial.
This study is design to find new efficacy biomarkers for IKERVIS® (1mg/mL ciclosporin) eye drops after 1 and 3 month after initiation of therapy. Additionally, this study intends to investigate whether IKERVIS® will help patients to better overcome situations of desiccating stress by exposing them to an adverse controlled environment (ACE) and analyzing both clinical and molecular parameters.
- Conditions
- Dry Eye, Dry Eye Syndromes, Severe Keratitis
- Being tested
- IKERVIS®1mg/mL
- Medical subject headings
- Dry Eye Syndromes, Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IKERVIS®1mg/mLDrug
One drop of study medication once daily in each eye at bedtime during 90 days.
| Study group | Role | What they receive |
|---|---|---|
| IKERVIS® (1mg/mL ciclosporin) eye drops | Experimental | Not described Receives: Drug: IKERVIS®1mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal fluoresceing staining
Significant reduction in corneal fluorescein staining
Measured: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment); V2 (30 days of treatment) vs V3 (90 days of treatment)
Secondary outcomes (2)
Response against adverse environmental conditions
Significant differences in the percentage of patients suffering a worsening in clinical signs and/or symptoms following exposure to adverse environmental conditions
Measured: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)
Molecular changes
Significant reduction in median expression of HLA-DR by conjunctival epithelial cells.
Measured: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start4 Feb 2020
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Collaborators
- Santen Oy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492878
- Sponsor's protocol ID
- IOBA-ImmunEyez_011-2018
- Status last verified
- Apr 2021
- First submitted
- 27 Jul 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valencia-Nieto L, Pinto-Fraga J, Blanco-Vazquez M, Fernandez I, Lopez-Miguel A, Garcia-Vazquez C, Gonzalez-Garcia MJ, Enriquez-de-Salamanca A, Calonge M. Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment. Ophthalmol Ther. 2024 May;13(5):1197-1210. doi: 10.1007/s40123-024-00906-1. Epub 2024 Mar 6.
PubMed 38446281
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Open-Label Clinical Trial to Evaluate the Efficacy of Ikervis® on Clinical Parameters and Molecular/Cellular Biomarkers in Dry Eye Patients With Severe Keratitis Who Have Not Improved Despite Regular Use of Tear Substitutes Before and After Exposure to an Adverse Controlled Environment
- ClinicalTrials.gov ID
- NCT04492878
- Acronym / sponsor ID
- IOBA-ImmunEyez_011-2018
- Conditions
- Dry Eye, Dry Eye Syndromes, Severe Keratitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Collaborators
- Santen Oy
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 30 Jul 2020 (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.
The proposed study is a prospective, open-label, unicentric, phase IV clinical trial.
This study is design to find new efficacy biomarkers for IKERVIS® (1mg/mL ciclosporin) eye drops after 1 and 3 month after initiation of therapy. Additionally, this study intends to investigate whether IKERVIS® will help patients to better overcome situations of desiccating stress by exposing them to an adverse controlled environment (ACE) and analyzing both clinical and molecular parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| IKERVIS® (1mg/mL ciclosporin) eye drops | Experimental | Drug: IKERVIS®1mg/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years.
- Diagnosis of DED with Severe Keratitis who have not improved despite regular use of tear substitutes by an ophthalmologist, at least 2 months previously.
- Not stable (as defined by the two items below) under at least 2 months of constant and regular use of artificial tears (at least 4 drops a day)
- Fluorescein corneal staining ≥ 2 (Oxford scale) in both eyes.
- DEQ-5 > 6 points
Key exclusion criteria (13 listed)
- Known allergy or sensitivity to the study product(s) or its components.
- Any ocular pathology other than DED.
- History of severe ocular inflammation other than that due to DED or infection in the 6 previous months to the study inclusion.
- Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution in the 6 previous months or any ocular or systemic surgery or procedure planned during the study duration that may affect the study as assessed by principal investigator.
- History of refractive surgery in the previous 18 months.
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 |
|---|---|---|
| IKERVIS®1mg/mLOne drop of study medication once daily in each eye at bedtime during 90 days. | Drug | IKERVIS® (1mg/mL ciclosporin) eye drops |
Primary outcome
Corneal fluoresceing staining
Time frame: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment); V2 (30 days of treatment) vs V3 (90 days of treatment)
Significant reduction in corneal fluorescein staining
2 secondary outcomes
Response against adverse environmental conditions
Time frame: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)
Molecular changes
Time frame: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Derived from this study: PubMed 38446281Valencia-Nieto L, Pinto-Fraga J, Blanco-Vazquez M, Fernandez I, Lopez-Miguel A, Garcia-Vazquez C, Gonzalez-Garcia MJ, Enriquez-de-Salamanca A, Calonge M. Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment. Ophthalmol Ther. 2024 May;13(5):1197-1210. doi: 10.1007/s40123-024-00906-1. Epub 2024 Mar 6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 IKERVIS®1mg/mL in people with Dry Eye and Dry Eye Syndromes, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
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 9 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: finished, as of the sponsor's last update on 21 Apr 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal fluoresceing staining (time frame: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment); V2 (30 days of treatment) vs V3 (90 days of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492878, which also lists 1 linked publication.
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 21 Apr 2021.