Severe Dry Eye Disease MedDRA version: 13.1 Level: PT Classification code 10013774 Term: Dry eye System Organ Class: 10015919 - Eye disorders MedDRA version: 13.1 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 10015919 - Eye disorders MedDRA version: 13.1 Level: PT Classification code 10023350 Term: Keratoconjunctivitis sicca System Organ Class: 10015919 - Eye disorders MedDRA version: 13.1 Level: LLT Classification code 10013778 Term: Dry eyes System Orga
Conditions
Interventions
Product Name: CYCLOKAT 1mg/ml (ciclosporin) eye drops, emulsion
Product Code: NOVA22007
Pharmaceutical Form: Eye drops*
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg/m
Sponsors
NOVAGALI Pharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, from 18 years of age. 2. Patients with persistent severe DED at the Screening and Baseline Visits 3. Patient must provide written informed consent. 4. Patient must be willing and able to undergo and return for scheduled study-related examinations. 5. The same eye (eligible eye) should fulfill all the above criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Dry eye disease resulting from the destruction of conjunctival goblet cells or scarring. 2. Any relevant ocular anomaly other than DED interfering with the ocular surface including trauma, post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history, etc. 3. Abnormal lid anatomy, abnormalities of the nasolachrymal drainage system or blinking function in either eye. 4. Anticipated use of temporary punctal plugs during the study. Patients with punctal plugs placed prior to screening are eligible for enrolment, however, punctual plugs must remain in place during the study. 5. Active herpes keratitis or history of ocular herpes. 6. Within the 90 days before the Screening Visit history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal). 7. History of non-infectious ocular inflammation not associated with dry eye (e.g. uveitis, scleritis, peripheral ulcerative keratitis). 8. Any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study. Patients taking BAK-free IOP lowering medications are eligible for study enrolment. 9. Patients with severe blepharitis and/or Meibomian Gland Disease (MGD). Patients enrolled with mild to moderate blepharitis and/or MGD should be treated as appropriate during the study. 10. Patients with active rosacea and/or progressive pterygium. 11. History of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye. 12. Contact lenses wear during the study. 13. Any prior refractive surgery (i.e., LASIK, LASEK, PRK, etc). These procedures are not allowed during the course of the study. 14. Ocular laser/surgery other than refractive surgery (including palpebral and cataract surgery) within 90 days before the study. Elective ocular laser/surgery is not allowed during the course of the study. 15. Best corrected distance visual acuity (BCDVA) score = +1.0 LogMAR (= 35 ETDRS letters, = 20/200 Snellen or = 0.1) in each eye.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - CFS score assessed with the modified Oxford scale. - OSDI score - VAS score - Schirmer Test score without anesthesia - Complete Corneal Clearing - Artificial Tear use - Investigator Global Evaluation of Efficacy ;Timepoint(s) of evaluation of this end point: Timepoints of evaluation of secondary endpoints will be at Month 1, 3, 6 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the superiority of CYCLOKAT® 1mg/ml (ciclosporin/cyclosporine) eye drops, emulsion over vehicle administered once daily in patients with severe DED after 6 months of treatment.;Secondary Objective: The secondary objective is to evaluate the ocular tolerability and overall ocular safety of CYCLOKAT® administered once daily in patients with severe DED over 12 months.;Primary end point(s): - an improvement from baseline of corneal fluorescein staining score (CFS) assessed with the modified Oxford scale - an improvement in OSDI score ;Timepoint(s) of evaluation of this end point: Month 6 | — |
Countries
Austria, Belgium, Czech Republic, Germany, Italy, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Information Help Desk
Iris-Pharma
Outcome results
None listed