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

NCT ID: NCT04144413

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2023-07-14

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

Conditions

Dry Eye Disease With Severe Keratitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Period 1 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.

Group Type: EXPERIMENTAL

Open-label Ikervis

Intervention Type: DRUG

NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.

Period 2 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.

Group Type: EXPERIMENTAL

Masked Ikervis

Intervention Type: DRUG

NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.

Period 2 Masked Vehicle

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.

Group Type: OTHER

Vehicle Comparator: Masked Vehicle

Intervention Type: OTHER

Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.

Interventions

Open-label Ikervis

NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.

Intervention Type: DRUG

Masked Ikervis

NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.

Intervention Type: DRUG

Vehicle Comparator: Masked Vehicle

Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.

2. The patient has signed and dated a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.

3. Male or female patient is aged 18 years or above.

4. At least 4 weeks of use of tear substitutes prior to the Baseline Visit

5. 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.

6. Patient must be willing and able to undergo and return for scheduled study-related examinations.

Exclusion Criteria

1. Active herpes keratitis or history of ocular herpes.

2. History of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the Baseline Visit.

3. 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.

4. Concurrent ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye.

5. 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.

6. Best corrected distance visual acuity (BCDVA) score ≤ 20/200 Snellen in each eye.

7. 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…).

8. Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc.).

9. History of ophthalmic malignancy

10. History of malignancy (other than ophthalmic) in the last 5 years.

11. 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.

12. Use of topical ciclosporin in the past 3 months prior to Baseline visit.

13. Any change in systemic immunosuppressant drugs within 30 days before the Baseline Visit or anticipated change during the course of the study.

14. Pregnancy or lactation at the Baseline Visit.

15. 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.

16. Participation in a clinical trial with an investigational substance within the past 30 days prior to Baseline Visit.

17. Participation in another clinical study at the same time as the present study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santen SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Sébastien GARRIGUE, PhD

Role: STUDY_CHAIR

Santen SAS

Locations

Fakultni Nemocnice Ostrava, Oční Klinika

Ostrava, Moravskoslezský kraj, Czechia

University Hospital Hradec Kralove

Hradec Králové, Nový Hradec Králové, Czechia

Ocni klinika OFTEX

Pardubice, Pardubický kraj, Czechia

MEDOKO s.r.o.

Prague, Prague, Czechia

Axon clinical s.r.o.

Prague, Prague, Czechia

Fakultní Nemocnice Brno

Brno, South Moravian, Czechia

Nemocnice Teplice, Ocni Oddeleni

Teplice, Ústecký kraj, Czechia

Masarykova nemocnice, Ocni oddeleni

Ústí nad Labem, Ústecký kraj, Czechia

Hospices Civils de Lyon - Hopital de la Croix-Rousse

Lyon, Auvergne-Rhône-Alpes, France

Hopitaux Universitaires Paris-Sud - Hopital Bicetre

Le Kremlin-Bicêtre, Île-de-France Region, France

Hôpital des Quinze-Vingts

Paris, Île-de-France Region, France

Hopitaux Universitaires Paris Nord Val de Seine - Hopital Bichat - Claude Bernard

Paris, Île-de-France Region, France

Universita degli Studi di Milano - Clinica Oculistica I

Milan, Lombardy, Italy

Universita degli Studi di Milano - Ospedale San Giuseppe - Clinica Oculistica (University Eye Clinic)

Milan, Lombardy, Italy

ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario - Clinica Oculistica III

Milan, Lombardy, Italy

Polo Universita degli Studi di Milano - Ospedale Luigi Sacco - Clinica Oculistica (Eye Clinic)

Milan, Lombardy, Italy

Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo - Clinica Oculistic

Pavia, Lombardy, Italy

Azienda Ospedaliera Universitaria Policlinico Gaetano Martino - Messina

Messina, Sicily, Italy

Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica

Padua, Veneto, Italy

Niepubliczny Zaklad Opieki Zdrowotnej Oko-Laser

Krakow, Lesser Poland Voivodeship, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 Klinika Diagnostyki i Mikrochirurgii Jaskry Oddział Okulistyki

Lublin, Lublin Voivodeship, Poland

Gabinet Okulistyczny Prof. Edward Wylęgała

Katowice, Silesian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne Śląskiego Uniwersytetu Medycznego w Katowicach

Katowice, Silesian Voivodeship, Poland

Retina Szpital Okulistyczny

Warsaw, Warszawskie, Poland

Uniwersytecki Szpital Kiliniczny IM. Jana Milkulicza-Radeckiego we Wroclawiu

Wroclaw, Wrocławiu, Poland

Federal State Institution Intersectoral Research and Technology Complex Eye microsurgery n.a. academician S.N. Fyodorov - Cheboksary

Cheboksary, Chuvashskaya Respublika, Russia

Ivanovo Regional Clinical Hospital

Ivanov, Ivanovo Oblast, Russia

State Budget Educational Institution of High Professional Education Moscow State Medical Stomatology University named after A.I.Evdokimov of MoH of RF

Moscow, Moscow, Russia

NMRC ISTC Eye Microsurgery n. a. Fyodorov - Moscow

Moscow, Moscow, Russia

Saint Petersburg State Pediatric Medical University

Saint Petersburg, Sankt-Peterburg, Russia

First Saint Petersburg State Medical University named after academician I.P. Pavlov

Saint Petersburg, Sankt-Peterburg, Russia

FSBI The Academician S.N. Fyodorov IRTC Eye Microsurgery of the Minzdrava - Novosibirsk

Novosibirsk, , Russia

GBOU VPO Omsk State Medical Academy, Ophthalmology Department

Omsk, , Russia

Saratov Railway Clinic

Saratov, , Russia

Cartujavision Oftalmologia

Seville, Andalusia, Spain

Hospital Clinico Universitario Lozano Blesa de Zaragoza

Zaragoza, Aragon, Spain

Hospital Universitario Donostia, Oftalmalogia

Donostia / San Sebastian, Basque Country, Spain

Institut Catala de Retina

Barcelona, Catalonia, Spain

Centro de Oftalmología Barraquer

Barcelona, Catalonia, Spain

Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

Barcelona, Catalonia, Spain

Fundación Oftalmológica del Mediterráneo

Valencia, , Spain

Bayındır Kavaklidere Hospital Ophthalmology department

Ankara, Anatolia, Turkey (Türkiye)

Ankara Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı Vehbi Koç Göz Hastanesi

Mamak, Ankara, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi Goz Hastaliklari Anabilim Dali

Bornova, İzmir, Turkey (Türkiye)

Selcuk University School of Medicine Ophthalmology department

Konya, Selcuklu, Turkey (Türkiye)

Countries

Czechia; France; Italy; Poland; Russia; Spain; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NVG14L127

Identifier Type: -

Identifier Source: org_study_id