3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)
- Conditions
- Dry Eye Disease With Severe Keratitis
- Interventions
- Registration Number
- NCT04144413
- Lead Sponsor
- Santen SAS
- Brief 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 once daily
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
-
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
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Period 2 Masked Ikervis Masked Ikervis 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. Period 1 Open-label Ikervis Open-label Ikervis 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.
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit Baseline, Months 3, 6, 9 and 12 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.
Trial Locations
- Locations (45)
Hopitaux Universitaires Paris-Sud - Hopital Bicetre
🇫🇷Le Kremlin-Bicêtre, Île-de-France, France
Hôpital des Quinze-Vingts
🇫🇷Paris, Île-de-France, France
Hopitaux Universitaires Paris Nord Val de Seine - Hopital Bichat - Claude Bernard
🇫🇷Paris, Île-de-France, France
Gabinet Okulistyczny Prof. Edward Wylęgała
🇵🇱Katowice, Silesia, Poland
Uniwersyteckie Centrum Kliniczne Śląskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, Silesia, Poland
Fakultní Nemocnice Brno
🇨🇿Brno, Jihomoravský, Czechia
Fakultni Nemocnice Ostrava, Oční Klinika
🇨🇿Ostrava, Moravskoslezský, Czechia
Ocni klinika OFTEX
🇨🇿Pardubice, Pardubický, Czechia
Axon clinical s.r.o.
🇨🇿Prague, Praha, Czechia
MEDOKO s.r.o.
🇨🇿Prague, Praha, Czechia
Masarykova nemocnice, Ocni oddeleni
🇨🇿Ústí Nad Labem, Ustecky, Czechia
Nemocnice Teplice, Ocni Oddeleni
🇨🇿Teplice, Ústecký, Czechia
Hospices Civils de Lyon - Hopital de la Croix-Rousse
🇫🇷Lyon, Rhône-Alpes, France
Universita degli Studi di Milano - Clinica Oculistica I
🇮🇹Milan, Lombardia, Italy
Universita degli Studi di Milano - Ospedale San Giuseppe - Clinica Oculistica (University Eye Clinic)
🇮🇹Milan, Lombardia, Italy
ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario - Clinica Oculistica III
🇮🇹Milan, Lombardia, Italy
Polo Universita degli Studi di Milano - Ospedale Luigi Sacco - Clinica Oculistica (Eye Clinic)
🇮🇹Milan, Lombardia, Italy
Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo - Clinica Oculistic
🇮🇹Pavia, Lombardia, Italy
Azienda Ospedaliera Universitaria Policlinico Gaetano Martino - Messina
🇮🇹Messina, Sicilia, Italy
Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica
🇮🇹Padova, Veneto, Italy
Samodzielny Publiczny Szpital Kliniczny Nr 1 Klinika Diagnostyki i Mikrochirurgii Jaskry Oddział Okulistyki
🇵🇱Lublin, Lubelskie, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Oko-Laser
🇵🇱Kraków, Malopolskie, Poland
Retina Szpital Okulistyczny
🇵🇱Warszawa, Warszawskie, Poland
Federal State Institution Intersectoral Research and Technology Complex Eye microsurgery n.a. academician S.N. Fyodorov - Cheboksary
🇷🇺Cheboksary, Chuvashia, Russian Federation
Uniwersytecki Szpital Kiliniczny IM. Jana Milkulicza-Radeckiego we Wroclawiu
🇵🇱Wrocław, Wrocławiu, Poland
Ivanovo Regional Clinical Hospital
🇷🇺Ivanov, Ivanovo, Russian Federation
NMRC ISTC Eye Microsurgery n. a. Fyodorov - Moscow
🇷🇺Moscow, Moskva, Russian Federation
Saint Petersburg State Pediatric Medical University
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
State Budget Educational Institution of High Professional Education Moscow State Medical Stomatology University named after A.I.Evdokimov of MoH of RF
🇷🇺Moskow, Moskva, Russian Federation
First Saint Petersburg State Medical University named after academician I.P. Pavlov
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
GBOU VPO Omsk State Medical Academy, Ophthalmology Department
🇷🇺Omsk, Russian Federation
FSBI The Academician S.N. Fyodorov IRTC Eye Microsurgery of the Minzdrava - Novosibirsk
🇷🇺Novosibirsk, Russian Federation
Saratov Railway Clinic
🇷🇺Saratov, Russian Federation
Hospital Clinico Universitario Lozano Blesa de Zaragoza
🇪🇸Zaragosa, Aragon, Spain
Cartujavision Oftalmologia
🇪🇸Sevilla, Andalucia, Spain
Institut Catala de Retina
🇪🇸Barcelona, Catalunya, Spain
Centro de Oftalmología Barraquer
🇪🇸Barcelona, Catalunya, Spain
Hospital Universitario Donostia, Oftalmalogia
🇪🇸San Sebastián, Euskal Autonomia Erkidegoa, Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
🇪🇸Barcelona, Catalunya, Spain
Bayındır Kavaklidere Hospital Ophthalmology department
🇹🇷Ankara, Anatolia, Turkey
Fundación Oftalmológica del Mediterráneo
🇪🇸Valencia, Spain
Ankara Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı Vehbi Koç Göz Hastanesi
🇹🇷Mamak, Ankara, Turkey
Ege Universitesi Tip Fakultesi Hastanesi Goz Hastaliklari Anabilim Dali
🇹🇷Bornova, Izmir, Turkey
Selcuk University School of Medicine Ophthalmology department
🇹🇷Konya, Selcuklu, Turkey
University Hospital Hradec Kralove
🇨🇿Hradec Králové, Nový Hradec Králové, Czechia