Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

NCT ID: NCT01751126

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-29
• Study Completion Date: 2016-02-29

Brief Summary

The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.

Conditions

Vernal Keratoconjunctivitis

Study Design

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

Study Groups

Ciclosporin

One drop of ciclosporin (NOVA22007) 1 mg/ml 4 times a day as monotherapy (morning, noon, afternoon and evening).

Group Type: EXPERIMENTAL

NOVA22007 ''Ciclosporin''

Intervention Type: DRUG

Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.

Ciclosporin/Placebo

One drop of ciclosporin (NOVA22007) 1 mg/ml twice a day and one drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.

Group Type: EXPERIMENTAL

NOVA22007 ''Ciclosporin''

Intervention Type: DRUG

Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.

Placebo

Intervention Type: DRUG

Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.

Placebo

One drop of placebo 4 times a day as monotherapy (morning, noon, afternoon and evening).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.

Interventions

NOVA22007 ''Ciclosporin''

Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.

Intervention Type: DRUG

Placebo

Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males or females from 4 to less than 18 years of age.
• History of at least one recurrence of vernal keratoconjunctivitis (VKC) in the past year prior to enrolment.

Exclusion Criteria

• Active severe VKC consistent with grade 3 or 4 of Bonini scale (Bonini 2007) with severe keratitis (grade 4 or 5 on the modified Oxford scale).
• Mean score of 4 subjective symptoms (photophobia, tearing, itching and mucous discharge) ≥ 60 mm using a 100 mm Visual Analogue Scale (where "0" means no symptom and "100" means the worst that have been ever experienced).

• Any relevant ocular anomaly other than VKC interfering with the ocular surface including trauma, post radiation keratitis, severe blepharitis, rosacea, corneal ulcer etc.
• Abnormal lid anatomy, abnormalities of the nasolacrimal drainage system or blinking function in either eye.
• Active herpes keratitis or history of ocular herpes.
• Active ocular infection (viral, bacterial, fungal, protozoal).
• Any ocular diseases other than VKC requiring topical ocular treatment during the course of the study.
• Contact lenses wear during the study.
• Topical and/or systemic use of corticosteroids within one week prior to enrolment.
• Topical ciclosporin (e.g. Restasis®), tacrolimus or sirolimus within 90 days prior to enrolment.
• Scraping of the vernal plaque within one month prior to the Baseline visit.
• Ocular surgery within 6 months prior to the Baseline visit (excluding surgical treatment of the vernal plaque).
• Disease not stabilized within 30 days before the Baseline Visit (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease, current systemic infections) or judged by the investigator to be incompatible with the study.
• Presence or history of severe systemic allergy.
• Any systemic immunosuppressant drugs within 90 days before the Baseline Visit.
• Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc).
• History of malignancy in the last 5 years.
• Pregnancy or lactation at the Baseline Visit.
• History of ocular varicella-zoster or vaccinia virus infection.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santen SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Glendale, CA, USA

Glendale, California, United States

Irvine, CA, USA

Irvine, California, United States

Rancho Cordova, CA, USA

Rancho Cordova, California, United States

Miami, FL, USA

Miami, Florida, United States

Zagreb, City of Zagreb, HR

Zagreb, City of Zagreb, Croatia

Marseille, Bouches-du-Rhône, FR

Marseille, Bouches-du-Rhône, France

Angers CEDEX 9, Maine-et-Loire, FR

Angers, Maine-et-Loire, France

Amiens CEDEX, Somme, FR

Amiens, Somme, France

Tours CEDEX 9, FR

Tours, , France

Paris CEDEX 8, Île-de-France, FR

Paris, Île-de-France Region, France

Mainz, Rhineland-Palatinate, DE

Mainz, Rhineland-Palatinate, Germany

Ioannina, Eprius, GR

Ioannina, Eprius, Greece

Thessaloniki, Macedonia, GR

Thessaloniki, Macedonia, Greece

Larissa, Thessaly, GR

Larissa, Thessaly, Greece

Szeged, Csongrád, HU

Szeged, Csongrád megye, Hungary

Debrecen, Hajdú-Bihar, HU

Debrecen, Hajdú-Bihar, Hungary

Budapest, HU

Budapest, , Hungary

Visakhapatnam, Andhra Pradesh, IN

Visakhapatnam, Andhra Pradesh, India

New Delhi, National Capitol Territory, IN

New Delhi, National Capitol Territory, India

Chennai, Tamil Nadu, IN

Chennai, Tamil Nadu, India

Lucknow, Uttar Pradesh, IN

Lucknow, Uttar Pradesh, India

Be'er-Sheva, IL

Beersheba, , Israel

Jerusalem, IL

Jerusalem, , Israel

Petah-Tikva, IL

Petah Tikva, , Israel

Rehovot, IL

Rehovot, , Israel

Tel-Aviv, IL

Tel Aviv, , Israel

Bologna, Emilia-Romagna, IT

Bologna, Emilia-Romagna, Italy

Lavagna, Liguria, IT

Lavagna, Liguria, Italy

Cinisello, Pisa, IT

Cinisello Balsamo, Pisa, Italy

Firenze, Tuscany, IT

Florence, Tuscany, Italy

Padova, Veneto, IT

Padua, Veneto, Italy

Messina, Messina, IT

Messina, , Italy

Vila Nova de Gaia, Douro Litoral, PT

Vila Nova de Gaia, Douro Litoral, Portugal

Lisboa, Extremadura, PT

Lisbon, Extremadura, Portugal

Lisboa, Extremadura, PT

Lisbon, Extremadura, Portugal

Torrevieja, Alicante, ES

Torrevieja, Alicante, Spain

Barakaldo, Biscay, ES

Barakaldo, Biscay, Spain

San Sebastián, Guipúzcoa, ES

San Sebastián, Guipúzcoa, Spain

Aranjuez, Madrid, ES

Aranjuez, Madrid, Spain

A Coruña, A Coruña, ES

A Coruña, , Spain

Alicante, Alicante, ES

Alicante, , Spain

Madrid, Madrid, ES

Madrid, , Spain

Madrid, Madrid, ES

Madrid, , Spain

Sevilla, Sevilla, ES

Seville, , Spain

Valencia, Valencia, ES

Valencia, , Spain

Valencia, Valencia, ES

Valencia, , Spain

Countries

United States; Croatia; France; Germany; Greece; Hungary; India; Israel; Italy; Portugal; Spain

Other Identifiers

NVG09B113

Identifier Type: -

Identifier Source: org_study_id