A MULTICENTER, RANDOMIZED, DOUBLE-MASKED, 2 PARALLEL ARM, VEHICLE CONTROLLED, 6-MONTH PHASE III TRIAL WITH A 6 MONTH OPEN LABEL TREATMENT SAFETY FOLLOW-UP PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF CYCLOKAT 1MG/ML (CICLOSPORIN/CYCLOSPORINE) EYE DROPS, EMULSION ADMINISTERED ONCE DAILY IN ADULT PATIENTS WITH SEVERE DRY EYE DISEASE (DED) - ND

• Conditions: Severe DED (Drye Eye Disease); MedDRA version: 13.1Level: PTClassification code 10013774Term: Dry eyeSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 13.1Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 13.1Level: PTClassification code 10023350Term: Keratoconjunctivitis siccaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 13.1Level: LLTClassification code 10013778Term: Dry eyesSystem Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2011-000160-97-IT
• Lead Sponsor: OVAGALI PHARMA S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-26
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

Patients will be eligible for inclusion in this study if all the following criteria are met: 1. Male or female, from 18 years of age. 2. Patients with persistent severe DED at the Screening and Baseline visits defined as the following: -?- Corneal fluorescein staining (CFS) score of 4 on the modified Oxford scale, AND - Schirmer test without anesthesia scored = 2mm/5min and <10 mm/5min AND - Ocular Surface Disease Index score = 23. 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

Ocular Conditions/Diseases 1. Patient with CFS grade 5 or below 4 on the modified Oxford scale. 2. Dry eye disease resulting from the destruction of conjunctival goblet cells or scarring. 3. Any relevant ocular anomaly other than DED interfering with the ocular surface including trauma, post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history, etc. 4. Abnormal lid anatomy, abnormalities of the nasolachrymal drainage system or blinking function in either eye. 5. 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. 6. Active herpes keratitis or history of ocular herpes. 7. Within the 90 days before the Screening Visit history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal). 8. History of non-infectious ocular inflammation not associated with dry eye (e.g. uveitis, scleritis, peripheral ulcerative keratitis). 9. 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. 10. 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. 11. Patients with active rosacea and/or progressive pterygium. 12. History of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye. 13. Contact lenses wear during the study. 14. Any prior refractive surgery (i.e., LASIK, LASEK, PRK, etc). These procedures are not allowed during the course of the study. 15. 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. 16. Best corrected distance visual acuity (BCDVA) score = +1.0 LogMAR (= 35 ETDRS letters, = 20/200 Snellen or = 0.1) in each eye. - Systemic or topical treatments that may affect the safety of the patinet or the interpretation of study results - Concomitant conditions that may affect the safety of the patinet or the interpretation of study results - situations that may affect patient compliance

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Efficacy endpoint (randomized, double-masked treatment period) Main composite responder endpoint at Month 6 defining responders as patients having simultaneously: -?- A 2 grade or more improvement from baseline of corneal fluorescein staining score (CFS) assessed with the modified Oxford scale AND -?- An improvement from baseline in OSDI score of at least 30%.;Main Objective: The primary objective of the study is to demonstrate the superiority of CYCLOKAT over vehicle in simultaneously improving signs and symptoms in severe DED patients following 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 at two timepoints: at Month 6, after the randomized, double-masked study treatment period and at Month 12, after open label safety treatment follow-up period.