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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: Santen SAS

Current Primary Outcome: Compare the composite efficacy score over 4 months of treatment base on keratitis and need for rescue medication for two different dosing regimens of NOVA22007 versus placebo (vehicle of the formulation). [ Time Frame: 12 months ]

Original Primary Outcome: Compare the efficacy of two different dosing regimens of NOVA22007 versus placebo (vehicle of the formulation) on both the evolution of severe keratitis and the need for rescue medication. [ Time Frame: 12 months ]

Current Secondary Outcome:

  • Tolerability of will be assessed monthly through slit lamp examination, BCDVA, IOP and safety through vital signs, AE reporting, CsA blood levels and biological tests. [ Time Frame: 12 months ]
  • The main secondary endpoints are the assessment of the corneal keratitis, the use of rescue therapy and the occurrence of ulcer which will be assessed monthly. [ Time Frame: 12 months ]


Original Secondary Outcome:

  • Assess the safety and tolerability including ocular tolerance of 2 dosing regimens of NOVA22007 versus placebo. [ Time Frame: 12 months ]
  • Assess the efficacy of 2 dosing regimens of NOVA22007 versus placebo on other signs and symptoms of vernal keratoconjunctivitis not covered in the primary objective. [ Time Frame: 12 months ]


Information By: Santen SAS

Dates:
Date Received: December 13, 2012
Date Started: March 2013
Date Completion: April 2016
Last Updated: August 5, 2015
Last Verified: August 2015