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NCT01751126 · ClinicalTrials.gov registry record · Phase 3
Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
A Phase 3 study, sponsored by Santen SAS.
- Completed
- Registry status
- Phase 3
- Development phase
- 169
- Enrollment target
NCT01751126: Completed Phase 3 study, sponsored by Santen SAS.
NCT01751126 is a Phase 3 study that has completed, run by Santen SAS. The registered enrollment target is 169 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01751126, a Phase 3 study, has completed, sponsored by Santen SAS.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 169 participants
- Enrollment target
Study Summary
The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.
Primary Outcome
Efficacy was assessed every month during the 4-month treatment phase and compared with Baseline using a composite criterion based on: * Keratitis assessed by the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5). On this modified scale, the score 0 corresponded to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represented complete corneal clearing. * Need for rescue medication. * Occurrence of corneal ulceration. An efficacy score was
Interventions
- DRUG Placebo
- DRUG NOVA22007 ''Ciclosporin''
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2013-04-29 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT01751126 record still lists
NCT01751126 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01751126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01751126 about?
NCT01751126 is a clinical study titled "Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis". The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of tr...
What is the current status of trial NCT01751126?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2013-04-29. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01751126?
The interventions under investigation include: Placebo (DRUG), NOVA22007 ''Ciclosporin'' (DRUG).
Who is sponsoring clinical trial NCT01751126?
This trial is sponsored by Santen SAS, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01751126's enrollment target sits among peer trials
169 1459th of 2000 higher than 542 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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