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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II/III, Multicenter, Double-Masked, Randomized, Parallel Group, Dose Ranging, Controlled Trial of Efficacy and Tolerance of Nova22007 (Cyclosporine A [CSA] 0.05% & 0.1% Ophthalmic Cationic Emulsion) Versus Vehicle in Patients With VKC

Conditions
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Conjunctivitis, Vernal

Intervention / Treatment
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* Drug: Cyclosporine NOVA22007 0.05%
* Drug: Cyclosporine NOVA22007 0.1%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least the two following signs, in at least one eye* (the same eye should fulfill both criteria): Presence of giant papillae with a diameter ≥ 1 mm on the upper tarsal conjunctiva AND Superficial keratitis At least two of the following ocular symptoms with a score > 2 in at least one eye*: burning/stinging, tearing, itching, pain, sticky eyelids, foreign body sensation, mucus discharge, and photophobia. Hyperemia score equal to or greater than 2. Exclusion Criteria: Concomitant corneal ulcer of infectious origin. Active ocular herpes Disease that could possibly interfere with the interpretation of the study results: active uveitis (defined by Tyndall score > 0), previous history of ocular hypertension or glaucoma, or condition incompatible with the frequent assessments needed by the study. Active herpes. History of malignancy or a recurrence in the last 5 years. Abnormality of nasolacrimal drainage apparatus. Concomitant disease not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, trouble with thyroid secretions, etc.) or judged by the investigator to be incompatible with the study (e.g. current systemic infections), or condition incompatible with the frequent assessments needed by the study. Known hypersensitivity to one of the components of the investigational medicinal products (IMP) or test products. Severe systemic allergy requiring systemic treatment at study entry. Female of childbearing potential. History of drug or alcohol addiction (> 50g/day, 5 glasses alcohol/day).

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOVA22007 0.05%<br>four times daily | Drug: Cyclosporine NOVA22007 0.05%<br> <br> |
| Experimental: NOVA22007 0.1%<br>four times daily | Drug: Cyclosporine NOVA22007 0.1%<br> <br> |
| Sham Comparator: Vehicle<br>administered four times daily | Drug: Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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): = Overall worsening of the subjective findings. = No change in the symptoms. = Slight improvement with the child still unable to participate in all normal daily activities. = Marked improvement despite temporary mild itching or mucus discharge. = Completely free of all symptoms. | 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): 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. The overall condition was assessed as better than before treatment in both eyes. Total re-epithelialisation of the cornea although slight conjunctival and perilimbal hyperaemia and papillary proliferations remains in both eyes. Only slight conjunctival hyperaemia without perilimbal injection or papillary proliferations in at least one eye Both eyes were quiet with no papillary proliferations or conjunctival or perilimbal injection. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I |  | Up to Month1 | 
| Ocular Tolerance in Period I | Are the tested eye drops (other than concomitant tear substitute ) comfortable? | Up to Month1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin