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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00814515

Enrollment

482

Registered

2008-12-25

Start date

2007-09-30

Completion date

2009-09-30

Last updated

2010-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Dry Eye Syndrome

Keywords

Moderate, Severe, Dry, Eye, Ciclosporin, Cyclosporine

Brief summary

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

Interventions

DRUGNOVA22007 (Ciclosporin 0.1%)

Ciclosporin 0.1% Ophthalmic Emulsions

DRUGNOVA22007

Vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026