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Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

NCT01751126 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2022-03-28

Study results available
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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.

Conditions

  • Vernal Keratoconjunctivitis

Interventions

DRUG

NOVA22007 ''Ciclosporin''

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Santen SAS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-29
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States
  • Croatia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01751126 on ClinicalTrials.gov