Clinical trial · Interventional
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
NCT00814515CI-TRIAL-00003672completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate to Severe Dry Eye Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NOVA22007 | Drug | — | UNRESOLVED |
| NOVA22007 (Ciclosporin 0.1%) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Ciclosporin 0.1%
- interventionNames
- Drug: NOVA22007 (Ciclosporin 0.1%)
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Vehicle
- interventionNames
- Drug: NOVA22007
Primary outcomes (2)
- measure
- Corneal fluorescein staining (on modified Oxford scale)
- timeFrame
- Approximately 26 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.