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Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)

NCT00328653 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-12-14

Study results available
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Summary

The primary objective of this study is:

* To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period.

The secondary objectives of this study are:

* To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;
* To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and
* To assess the decrease in frequency of concomitant artificial tears use.

Conditions

  • Conjunctivitis, Vernal

Interventions

DRUG

Cyclosporine NOVA22007 0.05%

DRUG

Cyclosporine NOVA22007 0.1%

DRUG

Vehicle

Sponsors & Collaborators

  • Santen SAS

    lead INDUSTRY

Principal Investigators

  • David BenEzra, Pf · Haddassah University Hospital

  • Christophe Baudouin, Pf. · Hôpital des XV-XX 28 rue de Charenton 75012 Paris

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-02-22

Countries

  • France

Study Locations

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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 NCT00328653 on ClinicalTrials.gov