A clinical trial to study the safety and efficacy of NOVA22007 1mg/ml (Ciclosporin) eye drops in children over 4 with active severe vernal keratoconjunctivitis

Phase 1

• Conditions: Vernal Keratoconjunctivitis (VKC); MedDRA version: 16.1Level: LLTClassification code 10057383Term: Allergic keratoconjunctivitisSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-005060-10-GR
• Lead Sponsor: ovagali Pharma S.A.S.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-22
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 168

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

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
7.Topical and/or systemic use of corticosteroids within one week prior to enrolment.
8.Topical ciclosporin (e.g. Restasis®), tacrolimus or sirolimus within 90 days prior to enrolment.
9.Scraping of the vernal plaque within one month prior to the baseline visit.
10.Ocular surgery within 6 months prior to the Baseline visit (excluding surgical treatment of the vernal plaque).

Systemic Conditions/Diseases or Treatments
11.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.
12.Presence or history of severe systemic allergy.
13.Any intake of systemic immunosuppressant drugs within 90 days before the Baseline Visit.
14.Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc).
15.History of malignancy in the last 5 years.
16.Pregnancy or lactation at the baseline Visit.

Compliance/Administrative
17.History of drug addiction or alcohol abuse.
18.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.
19.Patient not covered by a health insurance if required by the national legislation.
20.Participation in a clinical trial with an investigational substance within the past 30 days.
21.Participation in another clinical study at the same time as the present study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified