Dry Eye Disease With Severe KeratitisPhase 3NCT04144413

3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)

A Phase 3 study testing Open-label Ikervis and Masked Ikervis in people with Dry Eye Disease With Severe Keratitis, run by Santen SAS at 45 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The proposed 36-month Post Approval Efficacy Study (PAES) is a prospective, interventional, multicentre study to explore the long-term evolution of signs and symptoms, and occurrence of complications in Dry Eye Disease (DED) patients with severe keratitis receiving Ikervis® (1mg/mL ciclosporin) eye drops administered… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Disease With Severe Keratitis
What is being tested?: Open-label Ikervis and Masked Ikervis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 45 sitesin 7 countries
Study dates: 31 May 2019to 14 Jul 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
The patient has signed and dated a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Male or female patient is aged 18 years or above.
At least 4 weeks of use of tear substitutes prior to the Baseline Visit
DED patients with severe keratitis defined as the following:
CFS score of 3, 4 or 5 on the modified Oxford scale in at least one eye at Baseline Visits, AND

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Schirmer test without anaesthesia scored <10 mm/5min in the same eye at Baseline Visit, AND
At least two moderate to very severe symptoms of dry eye disease with a score ≥2 (severity graded on a 0 to 4 grade scale), among the following symptoms: burning/stinging, foreign body sensation, eye dryness, eye pain and blurred/poor vision at Baseline Visit.
Patient must be willing and able to undergo and return for scheduled study-related examinations.

Who cannot join

Active herpes keratitis or history of ocular herpes.
History of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the Baseline Visit.
Any ocular diseases other than DED requiring topical ocular treatment during the course of the study. Patients taking preservative-free IOP lowering medications are eligible for study enrolment.
Concurrent ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye.
Anticipated use of temporary punctal plugs during the study. Patients with punctal plugs placed prior to the Baseline Visit are eligible for enrolment; however, punctal plugs must remain in place during the study.
Best corrected distance visual acuity (BCDVA) score ≤ 20/200 Snellen in each eye.

Show all 17Show fewer

Presence or history of any systemic or ocular disorder, condition or disease that could possibly interfere with the conduct of the required study procedures or the interpretation of study results or judged by the investigator to be incompatible with the study (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease, current systemic infections, ocular infection…).
Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc.).
History of ophthalmic malignancy
History of malignancy (other than ophthalmic) in the last 5 years.
Anticipated change during course of the study in the dose of systemic medications that could affect a dry eye condition [mainly, estrogen-progesterone or other estrogen derivatives (only allowed for post-menopausal women), pilocarpine, isotretinoine, tetracycline, antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, phenothiazines, omega-3, systemic corticosteroids]. These treatments are allowed during the study provided they remain stable throughout the course of the study.
Use of topical ciclosporin in the past 3 months prior to Baseline visit.
Any change in systemic immunosuppressant drugs within 30 days before the Baseline Visit or anticipated change during the course of the study.
Pregnancy or lactation at the Baseline Visit.
Women of childbearing potential not using a medically acceptable, highly effective method of birth control (such as hormonal implants, injectable or oral contraceptives together with condoms, some intrauterine devices, sexual abstinence or vasectomised partner) from the Baseline Visit throughout the conduct of the study treatment periods and up to 2 weeks after the study end. Post-menopausal women (two years without menstruation) do not need to use any method of birth control.
Participation in a clinical trial with an investigational substance within the past 30 days prior to Baseline Visit.
Participation in another clinical study at the same time as the present study.

Trial locations and contacts

45 sites in 7 countries.

Country

City, postcode or hospital

45 sites in 7 countries

Russia9 sites

Federal State Institution Intersectoral Research and Technology Complex Eye microsurgery n.a. academician S.N. Fyodorov - Cheboksary
Cheboksary, Chuvashskaya Respublika, 428028
Ivanovo Regional Clinical Hospital
Ivanovo, Ivanovo Oblast, 153040
State Budget Educational Institution of High Professional Education Moscow State Medical Stomatology University named after A.I.Evdokimov of MoH of RF
Moscow, Moscow, 111398
NMRC ISTC Eye Microsurgery n. a. Fyodorov - Moscow
Moscow, Moscow, 126486
FSBI The Academician S.N. Fyodorov IRTC Eye Microsurgery of the Minzdrava - Novosibirsk
Novosibirsk, 630120
GBOU VPO Omsk State Medical Academy, Ophthalmology Department
Omsk, 644024
Saint Petersburg State Pediatric Medical University
Saint Petersburg, Sankt-Peterburg, 194100
First Saint Petersburg State Medical University named after academician I.P. Pavlov
Saint Petersburg, Sankt-Peterburg, 197002
Saratov Railway Clinic
Saratov, 41004

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Czechia8 sites

Fakultní Nemocnice Brno
Brno, South Moravian, 62500
University Hospital Hradec Kralove
Hradec Králové, Nový Hradec Králové, 50005
Fakultni Nemocnice Ostrava, Oční Klinika
Ostrava, Moravian-Silesian Region, 70800
Ocni klinika OFTEX
Pardubice, Pardubice Region, 53002
MEDOKO s.r.o.
Prague, Prague, 10800
Axon clinical s.r.o.
Prague, Prague, 15000
Nemocnice Teplice, Ocni Oddeleni
Teplice, Ústí nad Labem Region, 41505
Masarykova nemocnice, Ocni oddeleni
Ústí nad Labem, Ústí nad Labem Region, 4001

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Italy7 sites

Azienda Ospedaliera Universitaria Policlinico Gaetano Martino - Messina
Messina, Sicily, 98128
Universita degli Studi di Milano - Clinica Oculistica I
Milan, Lombardy, 20122
Universita degli Studi di Milano - Ospedale San Giuseppe - Clinica Oculistica (University Eye Clinic)
Milan, Lombardy, 20123
ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario - Clinica Oculistica III
Milan, Lombardy, 20142
Polo Universita degli Studi di Milano - Ospedale Luigi Sacco - Clinica Oculistica (Eye Clinic)
Milan, Lombardy, 20157
Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica
Padova, Veneto, 35128
Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo - Clinica Oculistic
Pavia, Lombardy, 27100

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Spain7 sites

Institut Catala de Retina
Barcelona, Catalonia, 8017
Centro de Oftalmología Barraquer
Barcelona, Catalonia, 8021
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, Catalonia, 8036
Hospital Universitario Donostia, Oftalmalogia
Donostia / San Sebastian, Basque Country, 20014
Cartujavision Oftalmologia
Seville, Andalusia, 41092
Fundación Oftalmológica del Mediterráneo
Valencia, 46015
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, Aragon, 50009

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Poland6 sites

Gabinet Okulistyczny Prof. Edward Wylęgała
Katowice, Silesian Voivodeship, 40594
Uniwersyteckie Centrum Kliniczne Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, Silesian Voivodeship, 40952
Niepubliczny Zaklad Opieki Zdrowotnej Oko-Laser
Krakow, Lesser Poland Voivodeship, 30644
Samodzielny Publiczny Szpital Kliniczny Nr 1 Klinika Diagnostyki i Mikrochirurgii Jaskry Oddział Okulistyki
Lublin, Lublin Voivodeship, 20079
Retina Szpital Okulistyczny
Warsaw, Warszawskie, 1364
Uniwersytecki Szpital Kiliniczny IM. Jana Milkulicza-Radeckiego we Wroclawiu
Wroclaw, Wrocławiu, 50556

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France4 sites

Hopitaux Universitaires Paris-Sud - Hopital Bicetre
Le Kremlin-Bicêtre, Île-de-France Region, 94270
Hospices Civils de Lyon - Hopital de la Croix-Rousse
Lyon, Auvergne-Rhône-Alpes, 69317
Hôpital des Quinze-Vingts
Paris, Île-de-France Region, 75012
Hopitaux Universitaires Paris Nord Val de Seine - Hopital Bichat - Claude Bernard
Paris, Île-de-France Region, 75877

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Turkey (Türkiye)4 sites

Bayındır Kavaklidere Hospital Ophthalmology department
Ankara, Anatolia, 6680
Ege Universitesi Tip Fakultesi Hastanesi Goz Hastaliklari Anabilim Dali
Bornova, İzmir, 35100
Selcuk University School of Medicine Ophthalmology department
Konya, Selcuklu, 42130
Ankara Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı Vehbi Koç Göz Hastanesi
Mamak, Ankara, 6620

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About this study

Official title: A Phase IIIb, Prospective, Interventional, Multicentre, 3-year Study to Explore the Long-term Evolution of Sign and Symptoms, and Occurence of Complications in Dry Eye Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)

Conditions: Dry Eye Disease With Severe Keratitis
Being tested: Open-label Ikervis, Masked Ikervis, Vehicle Comparator: Masked Vehicle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Open-label IkervisDrug
NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
Masked IkervisDrug
NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
Vehicle Comparator: Masked VehicleOther
Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.

Study groups in NCT04144413
Study group	Role	What they receive
Period 1 Open-label Ikervis	Experimental	Period 1 for all patients: IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Baseline for the first 12 months of treatment. Receives: Drug: Open-label Ikervis
Period 2 Masked Ikervis	Experimental	Period 2 for markedly improved patients at Month 12 only, and double-masked fashion. IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36. Receives: Drug: Masked Ikervis
Period 2 Masked Vehicle	Other	Other: Vehicle Comparator. Period 2 for markedly improved patients at Month 12 only, and double-masked fashion. Vehicle. Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36. Receives: Other: Vehicle Comparator: Masked Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
For analysis, SCC (Spearman Correlation Coefficient) and its 95% Confidence Interval were calculated for the correlation analysis between change from baseline in CFS (Corneal Fluorescein Staining) score at visit X and SANDE (Symptom Assessment iN Dry Eye) symptoms score using the FAS (Full Analysis Set) Period 1 Population.
Measured: Months 3, 6, 9, and 12

Secondary outcomes (1)

Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Period 1 is Baseline to Month 12 included. CFS is Corneal Fluorescein Score. Staining using fluorescein was graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 per area [cornea + nasal and temporal conjunctiva]) for cornea and conjunctiva separately. On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 corresponds to one staining dot per area.
A CFS grade of 0 represents complete corneal clearing.
Measured: Baseline, Months 3, 6, 9 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 201914 Jul 2023

First posted30 Oct 2019
Study start31 May 2019
Primary completion14 Jul 2023
Study completion14 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry Eye Disease With Severe KeratitisStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: In order to assess the response to IKERVIS® for DED patients with severe keratitis, after 12-month IKERVIS® (once daily) treatment, patients who have shown a marked improvement at Month 12 (as defined below) will be randomised to receive IKERVIS® or Vehicle (ration 3:2) in double-masked fashion.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04144413
Sponsor's protocol ID: NVG14L127
Status last verified: Aug 2024
First submitted: 25 Oct 2019
Last updated: 28 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Leonardi A, Aragona P, Sainz de la Maza M, Seleznev A, Wylegala E, Villani E, Baudouin C; Study Investigators. Long-Term Evolution of Treatment Outcomes with Once-Daily Ciclosporin A 0.1% Cationic Emulsion in Patients with Dry Eye Disease and Severe Keratitis. Ophthalmol Ther. 2026 Jul;15(7):2413-2429. doi: 10.1007/s40123-026-01411-3. Epub 2026 Jun 12.
PubMed 42283972

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Autologous Plasma Rich in Growth Factors for Severe Dry Eye Disease
Dry Eye Disease With Severe Keratitis
Active, not recruiting
3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
Dry Eye Syndromes
RecruitingPhase 4
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
Autoimmune Diseases, Dry Eye
Active, not recruitingPhase 4
DOMPE -MT Neurotrophic Keratitis
Dry Eye, Neurotrophic Keratitis

All Dry Eye Disease With Severe Keratitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIIb, Prospective, Interventional, Multicentre, 3-year Study to Explore the Long-term Evolution of Sign and Symptoms, and Occurence of Complications in Dry Eye Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)
ClinicalTrials.gov ID: NCT04144413
Acronym / sponsor ID: NVG14L127
Conditions: Dry Eye Disease With Severe Keratitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Santen SASIndustry (pharma, biotech, devices)
Study start: 31 May 2019 (actual)
Primary completion: 14 Jul 2023 (actual)
Study completion: 14 Jul 2023 (actual)
First posted: 30 Oct 2019 (actual)
Results: Posted 28 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: In order to assess the response to IKERVIS® for DED patients with severe keratitis, after 12-month IKERVIS® (once daily) treatment, patients who have shown a marked improvement at Month 12 (as defined below) will be randomised to receive IKERVIS® or Vehicle (ration 3:2) in double-masked fashion.

Arm	Type	Receives
Period 1 Open-label Ikervis	Experimental	Drug: Open-label IkervisPeriod 1 for all patients: IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Baseline for the first 12 months of treatment.
Period 2 Masked Ikervis	Experimental	Drug: Masked IkervisPeriod 2 for markedly improved patients at Month 12 only, and double-masked fashion. IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36.
Period 2 Masked Vehicle	Other	Other: Vehicle Comparator: Masked VehicleOther: Vehicle Comparator. Period 2 for markedly improved patients at Month 12 only, and double-masked fashion. Vehicle. Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
The patient has signed and dated a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Male or female patient is aged 18 years or above.
At least 4 weeks of use of tear substitutes prior to the Baseline Visit
DED patients with severe keratitis defined as the following:

Key exclusion criteria (17 listed)

Active herpes keratitis or history of ocular herpes.
History of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the Baseline Visit.
Any ocular diseases other than DED requiring topical ocular treatment during the course of the study. Patients taking preservative-free IOP lowering medications are eligible for study enrolment.
Concurrent ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye.
Anticipated use of temporary punctal plugs during the study. Patients with punctal plugs placed prior to the Baseline Visit are eligible for enrolment; however, punctal plugs must remain in place during the study.

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
Open-label IkervisNOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.	Drug	Period 1 Open-label Ikervis
Masked IkervisNOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.	Drug	Period 2 Masked Ikervis
Vehicle Comparator: Masked VehicleVehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.	Other	Period 2 Masked Vehicle

Primary outcome

The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Time frame: Months 3, 6, 9, and 12
For analysis, SCC (Spearman Correlation Coefficient) and its 95% Confidence Interval were calculated for the correlation analysis between change from baseline in CFS (Corneal Fluorescein Staining) score at visit X and SANDE (Symptom Assessment iN Dry Eye) symptoms score using the FAS (Full Analysis Set) Period 1 Population.

1 secondary outcome

Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Time frame: Baseline, Months 3, 6, 9 and 12

Results and safety

Results posted to the registry on 28 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period 1 Open-Label Treatment Ikervis	350	288
Period 2 Masked Treatment Ikervis	0	0
Period 2 Masked Treatment Vehicle	0	0

Primary outcome: The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.

Time frame: Months 3, 6, 9, and 12. Mean (95% Confidence Interval). Unit: Spearman Correlation Coefficient

Measure	Period 1 Open-Label Treatment Ikervis n = 336
Month 3 / Month 3	0.169 (0.060 to 0.274)
Month 3 / Month 6	0.245 (0.130 to 0.353)
Month 3 / Month 9	0.274 (0.160 to 0.380)
Month 3 / Month 12	0.178 (0.060 to 0.290)
Month 6 / Month 6	0.258 (0.144 to 0.365)
Month 6 / Month 9	0.322 (0.209 to 0.426)
Month 6 / Month 12	0.274 (0.158 to 0.382)
Month 9 / Month 9	0.343 (0.234 to 0.444)

Population analysed: Full Analysis Set (FAS). The number of analyzed data are participants evaluable for the outcome measure at Months 3, 6, 9, and 12. Comment3: Overall Number of Participants analyzed were 336 who received at least one dose of the study medication and had at least one post-baseline sign or symptom assessment of the study eye during Period 1. However, the discrepancy between each specific time-frame is due to missing data or patients withdrawn. These statistical methods were defined in a SAP.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1 Open-Label Treatment Ikervis	15 of 344 (4.4%)	138 of 344 (40.1%)	1 of 344
Period 2 Masked Treatment Ikervis	12 of 148 (8.1%)	58 of 148 (39.2%)	0 of 148
Period 2 Masked Treatment Vehicle	9 of 97 (9.3%)	39 of 97 (40.2%)	0 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42283972Leonardi A, Aragona P, Sainz de la Maza M, Seleznev A, Wylegala E, Villani E, Baudouin C; Study Investigators. Long-Term Evolution of Treatment Outcomes with Once-Daily Ciclosporin A 0.1% Cationic Emulsion in Patients with Dry Eye Disease and Severe Keratitis. Ophthalmol Ther. 2026 Jul;15(7):2413-2429. doi: 10.1007/s40123-026-01411-3. Epub 2026 Jun 12.

Related trials for Dry Eye Disease With Severe Keratitis

Not yet recruiting
Autologous Plasma Rich in Growth Factors for Severe Dry Eye Disease
Dry Eye Disease With Severe Keratitis
Active, not recruiting
3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
Dry Eye Syndromes
RecruitingPhase 4
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
Autoimmune Diseases, Dry Eye
Active, not recruitingPhase 4
DOMPE -MT Neurotrophic Keratitis
Dry Eye, Neurotrophic Keratitis

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.

Jean-Sébastien GARRIGUE, PhD study chair

Santen SAS

45 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Open-label Ikervis and Masked Ikervis in people with Dry Eye Disease With Severe Keratitis, run by Santen SAS at 45 sites in 7 countries.

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 17 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 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Russia, Czechia, Italy, Spain, Poland and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit. (time frame: Months 3, 6, 9, and 12). 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 NCT04144413, 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 28 Aug 2024.