Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Moderate to Severe Dry Eye Syndrome

Intervention / Treatment
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* Drug: NOVA22007 (Ciclosporin 0.1%)
* Drug: NOVA22007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 18 years of age or greater. At baseline, moderate to severe dry eye condition persisting despite conventional management. Exclusion Criteria: 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. 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. Any other ocular diseases requiring topical ocular treatment during the study period. Patient who has participated in a clinical trial with a new active substance during the past month before study entry. Participation in another clinical study at the same time as the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ciclosporin 0.1% | Drug: NOVA22007 (Ciclosporin 0.1%)<br>* Ciclosporin 0.1% Ophthalmic Emulsions<br>|
| Placebo Comparator: 2<br>Vehicle | Drug: NOVA22007<br>* Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal fluorescein staining (on modified Oxford scale) |  | Approximately 26 weeks | 
| Patient's global score of all symptoms of ocular discomfort unrelated to study medication instillation, using a visual analog scale (VAS) ranging from 0%-100% |  | Approximately 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Ocular Symptom Disease Index© (OSDI©) questionnaire • Percentage of complete responder to corneal fluorescein staining (on modified Oxford scale), i.e. with corneal staining score =0 • Patient's score of each symptom of ocular discomfort unrelated to |  | Approximately 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate, Severe, Dry, Eye, Ciclosporin, Cyclosporine