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Trial record 1 of 1 for:    NCT00328653
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Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)

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ClinicalTrials.gov Identifier: NCT00328653
Recruitment Status : Completed
First Posted : May 22, 2006
Results First Posted : December 14, 2021
Last Update Posted : December 14, 2021
Sponsor:
Information provided by:
Santen SAS

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Conjunctivitis, Vernal Drug: Cyclosporine NOVA22007 0.05% Drug: Cyclosporine NOVA22007 0.1% Drug: Vehicle Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: 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
Study Start Date : May 2006
Actual Primary Completion Date : February 22, 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NOVA22007 0.05%
four times daily
 Drug: Cyclosporine NOVA22007 0.05%
Experimental: NOVA22007 0.1%
four times daily
 Drug: Cyclosporine NOVA22007 0.1%
Sham Comparator: Vehicle
administered four times daily
 Drug: Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Overall Rating of Subjective Symptoms of VKC in Period I [ Time Frame: Week 4 ]

    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.

  2. Overall Rating of Objective Symptoms of VKC in Period I [ Time Frame: Week 4 ]

    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.


Secondary Outcome Measures :
  1. Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I [ Time Frame: Up to Month1 ]
  2. Ocular Tolerance in Period I [ Time Frame: Up to Month1 ]
    Are the tested eye drops (other than concomitant tear substitute ) comfortable?


Eligibility Criteria
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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328653


Locations
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France
Groupe Hospitalier Bichat-Claude Bernard
Paris, France, 75018
Sponsors and Collaborators
Santen SAS
Investigators
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Principal Investigator: David BenEzra, Pf Haddassah University Hospital
Study Director: Christophe Baudouin, Pf. Hôpital des XV-XX 28 rue de Charenton 75012 Paris
More Information
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ClinicalTrials.gov Identifier: NCT00328653    
Other Study ID Numbers: NOVATIVE - NVG05L101
First Posted: May 22, 2006    Key Record Dates
Results First Posted: December 14, 2021
Last Update Posted: December 14, 2021
Last Verified: November 2021
Keywords provided by Santen SAS:
vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin
Additional relevant MeSH terms:
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Conjunctivitis
Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyclosporine
 Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors