At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 169 enrolled

Drug / intervention

NOVA22007 ''Ciclosporin'' +1 moredrug

Likely dose

NOVA22007 ''Ciclosporin'' 1 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01751126

NCT01751126Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis

Santen SAS·interventional·Posted Dec 17, 2012·Updated Mar 28, 2022

In Brief

A Phase 3 clinical trial evaluating NOVA22007 ''Ciclosporin'' and Placebo for Vernal Keratoconjunctivitis. Completed, enrolled 169 participants across 46 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsVernal Keratoconjunctivitis

CountriesCroatia, France, Germany, Greece, Hungary, India, Israel, Italy, Portugal, Spain, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedDec 2012

Enrollment StartApr 2013

Primary CompletionFeb 2016

TodayJul 2026

First PostedDec 17, 2012

Enrollment StartApr 29, 2013

Primary CompletionFeb 1, 2016

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 13.5 years ago

Interventions

NOVA22007 ''Ciclosporin''drug

Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.

Placebodrug

Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.