6-MONTHS EFFICACY AND SAFETY CLINICAL TRIAL FOLLOWED BY 6-MONTHS OF SAFETY EVALUATION OF CYCLOKAT® 1MG/ML (CICLOSPORIN) EYE DROPS, EMULSION ADMINISTERED ONCE DAILY IN ADULT PATIENTS WITH SEVERE DRY EYE DISEASE (DED)

Conditions: Severe Dry Eye Disease
MedDRA version: 14.0Level: PTClassification code 10013774Term: Dry eyeSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 14.0Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 14.0Level: LLTClassification code 10013778Term: Dry eyesSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 14.0Level: PTClassification code 10023350Term: Keratoconjunctivitis siccaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2011-000160-97-AT

Lead Sponsor: OVAGALI Pharma S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 272

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 136
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 136

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>- an improvement in OSDI score;Timepoint(s) of evaluation of this end point: Month 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - CFS score assessed with the modified Oxford scale. <br>- OSDI score <br>- VAS score <br>- Schirmer Test score without anesthesia<br>- Complete Corneal Clearing<br>- Artificial Tear use <br>- 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

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