Vernal Keratoconjunctivitis (VKC) MedDRA version: 18.1 Level: LLT Classification code 10057383 Term: Allergic keratoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: Ciclosporin
Product Code: NOVA22007
Pharmaceutical Form: Eye drops, emulsion
INN or Proposed INN: Ciclosporin
CAS Number: 59865-13-3
Current Sponsor code: 081400
Other descriptive name:
Sponsors
Novagali Pharma S.A.S.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Documented informed consent form signed by the subject or legal guardian and assent of the child, as appropriate, in accordance with local regulation and legal requirements. Assent will be required (as applicable) for children per local regulation and for those who, in the investigator’s judgment, are able to comprehend. 2.Male or female patients from 4 to less than18 years of age. 3.Female of childbearing potential must have a negative pregnancy test plus 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 vasectomized partner) throughout the conduct of the study and up to 2 weeks after the study end. 4.History of at least one recurrence of VKC in the past year prior to enrolment. 5.Patients not receiving any treatment for an established and active VKC; or patients already receiving treatment for their VKC provided treatment is stopped according to the wash-out period specified in the exclusion criteria. 6.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). 7.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). 8.Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 9.Patient enrollment must occur early during the site VKC season in order to allow the 4 month treatment period during the site VKC season. Are the trial subjects under 18? yes Number of subjects for this age range: 168 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Ocular Conditions/Diseases: 1.Any relevant ocular anomaly other than VKC interfering with the ocular surface including trauma, post radiation keratitis, severe blepharitis, rosacea, corneal ulcer etc. 2.Abnormal lid anatomy, abnormalities of the nasolacrimal drainage system or blinking function in either eye. 3.Active herpes keratitis or history of ocular herpes. 4.History of ocular varicella-zoster or vaccinia virus infection. 5.Active ocular infection (viral, bacterial, fungal, protozoal). 6.Any ocular diseases other than VKC requiring topical ocular treatment during the course of the study. 7.Contact lenses wear during the study. Ocular Treatments 8.Topical and/or systemic use of corticosteroids within one week prior to enrolment. 9.Topical ciclosporin (e.g. Restasis®), tacrolimus or sirolimus within 90 days prior to enrolment. 10.Scraping of the vernal plaque within one month prior to the baseline visit. 11.Ocular surgery within 6 months prior to the Baseline visit (excluding surgical treatment of the vernal plaque). Systemic Conditions/Diseases or Treatments 12.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. 13.Presence or history of severe systemic allergy. 14.Any intake of systemic immunosuppressant drugs within 90 days before the Baseline Visit. 15.Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc). 16.History of malignancy in the last 5 years. 17.Pregnancy or lactation at the baseline Visit. Compliance/Administrative 18.History of drug addiction or alcohol abuse. 19.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. 20.Patient not covered by a health insurance if required by the national legislation. 21.Participation in a clinical trial with an investigational substance within the past 30 days. 22.Participation in another clinical study at the same time as the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the efficacy of two different dosing regimens of NOVA22007 versus placebo (vehicle of the formulation) on both the evolution of severe keratitis and the need for rescue medication.;Secondary Objective: The secondary objectives of the study are: i)To assess the safety and tolerability including ocular tolerance of 2 dosing regimens of NOVA22007 versus placebo. ii)To assess the efficacy of 2 dosing regimens of NOVA22007 versus placebo on other signs and symptoms of VKC not covered in the primary objective. ;Primary end point(s): Composite efficacy score at 4 months, defined as the mean of the 4 efficacy scores taken at each monthly visit. Efficacy will be assessed every month during the 4 month treatment period and compared with baseline using a composite criterion based on: -Keratitis assessed by the modified Oxford scale -Need for rescue medication -Occurrence of corneal ulceration Efficacy score will be calculated as followed: Patient’s score at month X= CFS (baseline) – CFS (Month X) + penalty (ies) Penalty for rescue medication: -1 (per course, with a maximum of 2 courses between 2 scheduled visits) Penalty for corneal ulceration: -1 (per occurrence) ;Timepoint(s) of evaluation of this end point: Monthly for 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy criteria •Use of rescue medication: the total number of topical steroid courses will be assessed at each visit during the 4 month efficacy evaluation treatment period. •Keratitis assessed by the modified Oxford grading scale at each visit during the 4 month efficacy evaluation treatment period. •The 4 main symptoms (photophobia, tearing, itching and mucous discharge) assessed using a 100 mm VAS, individually and globally (average of the 4 measures) at each visit during the 4 month efficacy evaluation treatment period. •Responder: Patient 1) with a CFS score at Month 4 equal or smaller than 50% of the baseline CFS, 2) who did not withdrew from the trial for a reason possibly due to treatment, 3) free from occurrence of ulceration and use of recue medication in the last three months of treatment •Objective signs: hyperaemia, conjunctival discharge, papillae and limbal infiltrates at each visit during the 4 month efficacy evaluation treatment period. •QUICK questionnaire assessed at baseline and months 1 to 4. •Investigator global assessment of the efficacy at each visit except at baseline. •Artificial tear use during the 4 month efficacy evaluation treatment period Safety/Tolerability criteria •Local ocular tolerance •Best corrected visual acuity •Incidence and severity of adverse events •CsA blood levels and creatinine levels, alanine aminotransferase (AST) and aspartate aminotransferase (ALT) at baseline, month 2, month 4, and month 12. ;Timepoint(s) of evaluation of this end point: Monthly for 4 months. The CsA blood levels and creatinine levels, alanine aminotransferase (AST) and aspartate aminotransferase (ALT) at will be done at baseline, month 2, month 4, and month 12. | — |
Countries
Croatia, France, Germany, Greece, Hungary, India, Israel, Italy, Portugal, Singapore, Spain, United States
Contacts
Public ContactSharon Rouse
Chiltern
Outcome results
None listed