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

NCT ID: NCT00328653

Last Updated: 2021-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

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.

Detailed Description

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Conditions

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Conjunctivitis, Vernal

Keywords

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vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Study Groups

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NOVA22007 0.05%

four times daily

Group Type EXPERIMENTAL

Cyclosporine NOVA22007 0.05%

Intervention Type DRUG

NOVA22007 0.1%

four times daily

Group Type EXPERIMENTAL

Cyclosporine NOVA22007 0.1%

Intervention Type DRUG

Vehicle

administered four times daily

Group Type SHAM_COMPARATOR

Vehicle

Intervention Type DRUG

Interventions

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Cyclosporine NOVA22007 0.05%

Intervention Type DRUG

Cyclosporine NOVA22007 0.1%

Intervention Type DRUG

Vehicle

Intervention Type DRUG

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).
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen SAS

INDUSTRY

Sponsor Role lead

Principal Investigators

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David BenEzra, Pf

Role: PRINCIPAL_INVESTIGATOR

Haddassah University Hospital

Christophe Baudouin, Pf.

Role: STUDY_DIRECTOR

Hôpital des XV-XX 28 rue de Charenton 75012 Paris

Locations

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Groupe Hospitalier Bichat-Claude Bernard

Paris, , France

Site Status

Countries

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France

References

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Leonardi A, Pisella PJ, Benitez-Del-Castillo JM, Amrane M, Ismail D, Doan S, Bremond-Gignac D. NOVATIVE: A Phase II/III, Multicenter, Double-masked, Randomized Study of Cyclosporine A 0.05% and 0.1% Ophthalmic Cationic Emulsion Versus Vehicle in Patients with Vernal Keratoconjunctivitis. Clin Ther. 2023 Dec;45(12):1284-1288. doi: 10.1016/j.clinthera.2023.09.022. Epub 2023 Oct 21.

Reference Type DERIVED
PMID: 37872059 (View on PubMed)

Other Identifiers

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NOVATIVE - NVG05L101

Identifier Type: -

Identifier Source: org_study_id