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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
118
Groupe Hospitalier Bichat-Claude Bernard
Paris, France
Overall Rating of Subjective Symptoms of VKC in Period I
The primary criteria of the trial was the overall rating of subjective symptoms in ocular symptoms of VKC as compared to Baseline and assessed at Week 4 (Month 1) based on a five-point scale based on BenEzra trial (BenEzra 1986): 1. = Overall worsening of the subjective findings. 2. = No change in the symptoms. 3. = Slight improvement with the child still unable to participate in all normal daily activities. 4. = Marked improvement despite temporary mild itching or mucus discharge. 5. = Completely free of all symptoms.
Time frame: Week 4
Overall Rating of Objective Symptoms of VKC in Period I
Overall rating of objective signs was to be assessed under the slit lamp by the Investigator and recorded on a five-point scale based on BenEzra trial (BenEzra 1986): 1. Intense congestion of conjunctival vessels, perilimbal injection, or corneal involvement with the papillary proliferations more extensive or similar to the situation recorded before treatment in at least one of the eyes. 2. The overall condition was assessed as better than before treatment in both eyes. 3. Total re-epithelialisation of the cornea although slight conjunctival and perilimbal hyperaemia and papillary proliferations remains in both eyes. 4. Only slight conjunctival hyperaemia without perilimbal injection or papillary proliferations in at least one eye 5. Both eyes were quiet with no papillary proliferations or conjunctival or perilimbal injection.
Time frame: Week 4
Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I
Time frame: Up to Month1
Ocular Tolerance in Period I
Are the tested eye drops (other than concomitant tear substitute ) comfortable?
Time frame: Up to Month1
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