A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome - SICCANOVE

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 482

Inclusion Criteria

1. Males or females 18 years of age or greater.
2. At baseline, moderate to severe dry eye condition persisting despite conventional management (which may include artificial tear drops, gels or ointments and punctual occlusion), and defined as the following:
• At least one moderate to severe symptom of dry eye with a score =2 (severity graded on a 4-point scale) i.e., burning/stinging, foreign body sensation, itching, eye dryness, pain, blurred vision or sticky feeling and photophobia AND
• Tear Break Up time = 8 seconds AND
• Corneal fluorescein staining = 2 and = 4 (modified Oxford scale, scale 0-5) AND
• Schirmer tear test without anaesthesia of = 2mm/5min and <10 mm/5min AND
• Lissamine green staining > 4 (Van Bijsterveld scale, scale 0-9)
The same eye (eligible eye) should fulfil all the above criteria.
3. Patient must provide written informed consent.
4. Patient must be willing and able to undergo and return for scheduled study-related examinations.

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

1. Best corrected distance visual acuity (BCDVA) score > + 0.7 Log Mar in the eligible eye.
2. Dry eye resulting from the destruction of conjunctival goblet cells or scarring.
3. Abnormal lid anatomy or blinking function.
4. Abnormalities of the nasolachrymal drainage system.
5. Presence or history of any systemic or ocular disorder or condition, including ocular surgery, trauma or disease that could possibly interfere with the interpretation of study results.
6. Any relevant ocular anomaly interfering with the ocular surface, including post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history or concomitant corneal ulcer of infectious origin, etc.
7. Any ocular surgery or laser (including palpebral, refractive and cataract surgery/laser) within 6 months before study entry in the eligible eye and within 3 months prior study entry in the non-eligible eye.
8. History of ocular trauma, infection (viral, bacterial, fungal), or ocular inflammation (Tyndall ? 0) as well as ocular inflammation signs not associated with KCS within the 3 months before the Screening Visit.
9. Patients with severe blepharitis not related to dry eye or Sjögren syndrome, acute lesions of rosacea and/or progressive pterygium.
10. Any other ocular diseases requiring topical ocular treatment during the study period.
11. Presence or history of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye.
12. Active or history of ocular herpes.
13. History of malignancy in the last 5 years (with the exception of basal cell carcinoma and cervix carcinoma).
14. Systemic disease not stabilized within 1 month before the Screening Visit (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or condition incompatible with the frequent assessments needed by the study.
15. Known hypersensitivity to one of the components of the study or procedural medications (fluorescein, lissamine green, oxybuprocaine, etc.).
16. Presence or history of severe systemic allergy.
17. Any change within 1 month prior study entry of systemic medication that could affect a dry eye condition (e.g., estrogen-progesterone or other estrogen derivatives (only for post-menopausal women), antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, phenothiazines, omega-3, systemic corticosteroids etc…). These treatments are allowed during the study provided they remain stable throughout the course of the study.
18. Use of systemic or topical CsA (i.e., Restasis®), tacrolimus or sirolimus, within 6 months prior study entry.
19. Use of topical corticosteroids or prostaglandins within one month before study entry.
20. Any change within 1 month prior study entry of systemic pilocarpine, isotretinoine or tetracycline, as well as the use of topical pilocarpine or isotretinoine within 1 month before study entry. The systemic treatments (pilocarpine, isotretinoine or tetracycline) are allowed during the study provided they remain stable throughout the course of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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