| CTRI Number |
CTRI/2014/06/004669 [Registered on: 13/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
20/07/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Placebo in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis (a recurrent ocular inflammatory disease)
|
|
Scientific Title of Study
|
A Multicenter, Randomized double masked, 3 parallel arms, placebo controlled study to assess the efficacy and safety of NOVA22007 1Mg/Ml (ciclosporin/ cyclosporine) eye drops, emulsion administered in paediatric patients with active severe Vernal Keratoconjunctivitis with severe keratitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2007-000029-23 |
EudraCT |
| NVG09B113 Final Versions 01 Dated 16 Nov 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rupali Mokashi |
| Designation |
Medical Officer |
| Affiliation |
Chiltern International Pvt Ltd |
| Address |
802, Alpha, Main Street
Hiranandani Business Park,
Powai, Mumbai – 400076
Mumbai
MAHARASHTRA
400076
India |
| Phone |
91-22-40982700 |
| Fax |
91-22-40982727 |
| Email |
rupali.mokashi@chiltern.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Mokashi |
| Designation |
Medical Officer |
| Affiliation |
Chiltern International Pvt Ltd |
| Address |
802, Alpha, Main Street
Hiranandani Business Park,
Powai, Mumbai – 400076
MAHARASHTRA
400076
India |
| Phone |
91-22-40982700 |
| Fax |
91-22-40982727 |
| Email |
rupali.mokashi@chiltern.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sandeep Adsule |
| Designation |
Director |
| Affiliation |
Chiltern International Pvt Ltd |
| Address |
802, Alpha, Main Street
Hiranandani Business Park,
Powai, Mumbai – 400076
Mumbai
MAHARASHTRA
400076
India |
| Phone |
91-22-40982700 |
| Fax |
91-22-40982727 |
| Email |
sandeep.adsule@chiltern.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NOVAGALI PHARMA SAS |
| Address |
Genopole Industries, Genavenir IV, 1 rue Pierre fontaine, F-91058 Evry, France |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Israel
Singapore
Turkey
France
Germany
Hungary
India
Italy
Portugal
Spain
United States of America |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Ramgopal Bang |
Ganpati Nethralaya |
Department of Ophthalmology,
Survey No 204/2
Devalgaonraja - Mantha road
Jalna - 431203
Maharashtra
Jalna
MAHARASHTRA |
91-9657655211
drrohitbang@gmail.com |
| Dr Vupputuri Venkata lakshmi Narasimha Rao |
Government Regional Eye Hospital |
Department of Ophthalmology, Resaveripalem, Vishakapatnam,Andhra Pradesh-530002
Visakhapatnam
ANDHRA PRADESH |
91-9885268979
vvlclinicalresearch@gmail.com |
| Dr Ritu Arora |
Guru Nanak Eye Centre |
Maulana Azad Medical College,
Department of Ophthalmology,
Maharaja Ranjit Singh Marg,
New Delhi - 110002
New Delhi
DELHI |
91-9810371022
dr_rituarora@yahoo.com |
| Dr Shanta Motwane |
K.J.Somaiya Hospital |
Department of Ophthalmology, Priyadarshini, Sion East, Mumbai - 400022
Mumbai
MAHARASHTRA |
91-9820338252
shantamotwane@hotmail.com |
| Dr Sheela Kerkar |
KEM Hospital |
Department of Ophthalmology, Acharya Donde Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA |
91-9820297576
sheelakerkar@gmail.com |
| Dr Siddharth Agarwal |
King Georges Medical University |
Department of Ophthalmology, Chowk, Lucknow - 226003, Uttar Pradesh
Lucknow
UTTAR PRADESH |
91-9336815667
drsiddharth01@gmail.com |
| Dr Srikant Sahu |
L.V.Prasad Eye Hospital |
Department of Ophthalmology, Bhubaneshwar campus, Patia, Bhubaneshwar – 751024, Orissa, India.
Khordha
ORISSA |
91-9439488888
srikantsahu@lvpei.org |
| Dr Ananth Bhandary |
Medisys Clinisearch Pvt Ltd |
Bangalore Diabetes Centre, No: 426, 4th Cross 2nd Block, Kalyan Nagar, Bangalore - 560043, Karnataka, India
Bangalore
KARNATAKA |
91-9845832789
fundary@yahoo.com |
| Dr Himadri Datta |
Regional Institutute of Ophthalmology |
Department of Cornea, College street, Kolkatta - 700073, West Bengal, India
Kolkata
WEST BENGAL |
91-9830127929
himadri.datta@gmail.com |
| Dr Racapalle Reddy Sudhir |
Sankara Nethralaya Hospital |
Department of Ophthalmology, No:18, College Road, Nungamabakkam, Chennai – 600 006, Tamilnadu, India
Chennai
TAMIL NADU |
91-9381751624
rrsudhir@hotmail.com |
| Dr Yasmin Rusi Bhagat |
St. Georges Hospital |
Department of Ophthalmology, P.D.Mello road, Fort, Mumbai – 400001, Maharashtra, India.
Mumbai
MAHARASHTRA |
91-9892114375
ruyazb@gmail.com |
| Dr Kini Kulai Shobha |
Vasan Eye Care Hospital |
Department of Ophthalmology,60/1-60/8, Advaitha Ashram road, Salem - 636004, Tamilnadu, India
Salem
TAMIL NADU |
91-9786400100
slmkiniks@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
| Ethics committee for Research on Human Subjects, KEM Hospital, Mumbai |
Approved |
| Ethics Committee of K.J. Somaiya Medical College & Hospital, Mumbai |
Approved |
| Ethics sub Committee, Vision Research Foundation |
Approved |
| Institutional Ethics Commitee, Maulana Azad Medical College |
Approved |
| Institutional Ethics Committe, King George Medical University |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vernal KeratoConjuntivitis with Severe Keratitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOVA22007 |
Dose: 1mg/ml Ciclosporine
Frequency: 4 times a day
Route of administration: Instillation drops.
Total Duration - 12 months |
| Comparator Agent |
Placebo |
Dose: 0mg/ml Ciclosporine
Frequency: 4 times a day
Route of Administration: Instillation drops
Total Duration - 12 months |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1.Documented informed consent form 2. Male or female patients from 4 to less than18 years of age. 3. Female of childbearing potential
4. History of at least one recurrence of VKC
5. Patients not receiving any treatment for an established and active VKC.
6. Active severe VKC
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. |
|
| ExclusionCriteria |
| Details |
Ocular Conditions/Diseases:
1. Any relevant ocular anomaly .
2. Abnormal lid anatomy.
3. Active herpes keratitis.
4. History of ocular varicella-zoster.
5. Active ocular infection.
6. Any ocular diseases other than VKC requiring topical ocular treatment during the course of the study.
Contact lenses wear.
7. Topical and/or systemic use of corticosteroids.
8. Topical ciclosporin (e.g. Restasis®), tacrolimus or sirolimus.
9. Scraping of the vernal plaque.
10. Ocular surgery within 6 months prior to the Baseline visit.
11. Disease not stabilized within 30 days before the Baseline Visit.
12. Presence or history of severe systemic allergy.
13. Any intake of systemic immunosuppressant drugs.
14. Known hypersensitivity to one of the components of medications.
15. History of malignancy.
Compliance/Administrative
16.Pregnancy or lactation at the baseline Visit.
17. History of drug addiction or alcohol abuse.
18. Presence or history of any systemic or ocular disorder.
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
4 months (Composite efficacy score at 4 months, defined as the mean of the efficacy scores taken at each monthly visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objectives of the study are:
To assess the safety and tolerability including ocular tolerance of 2 dosing regimens of NOVA22007 versus placebo.
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. |
Months 1, 2, 3, 4, 6, 8, 10 & 12 |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/06/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
29/04/2013 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/ml (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered In Paediatric Patients with Active Severe Vernal Keratoconjunctivitis with Severe Keratitis. The study will be conducted in 11 countries recruiting 168 patients globally. In India the study will be conducted in 8 sites. The primary 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 VKC after 4 months of treatment. The secondary objectives are to assess the safety and the tolerability including ocular tolerance of 2 dosing regimens of NOVA22007 versus placebo and to assess the efficacy of the 2 dosing regimens of NOVA22007 versus placebo on other signs and symptoms of VKC not covered in the primary objective. The first patient recruitment is being expected in June 2014. |