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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-004473-26
    Sponsor's Protocol Code Number:LT0427-PII-01/07
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-08-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2007-004473-26
    A.3Full title of the trial
    Efficacy and safety of sodium cromolyn eye drops compared with placebo eye drops in patients with a history of allergic conjunctivitis using the Conjunctival Allergen Challenge model.
    A.4.1Sponsor's protocol code numberLT0427-PII-01/07
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratoires Théa
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cromabak
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Théa
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCromabak
    D.3.4Pharmaceutical form Eye drops*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcromoglicate de sodium
    D.3.9.2Current sponsor codeT0427
    D.3.9.3Other descriptive nameCromabak
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops*
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    allergic conjunctivitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001709
    E.1.2Term Allergic conjunctivitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy of sodium cromolyn preservative-free ophthalmic solution compared with placebo in the prevention of symptoms of allergic conjunctivitis induced by Conjunctival Allergen Challenge (CAC) (see Appendix II) in patients with a known history of allergic conjunctivitis.
    This will be assessed through the primary endpoint, which is the itching subject’s assessment by a 5-point scale, 5 minutes after the CAC.
    E.2.2Secondary objectives of the trial
    Conjunctival hyperaemia
    Tearing.
    Chemosis.
    Eyelid swelling
    Ocular global discomfort assessed by the subject using a Visual Analog scale 15 minutes after the study drugs instillation test.
    Comparison of tolerability of sodium cromolyn and placebo eye drops will be assessed using global assessments by subject) and reporting of Adverse Events, at visit 3.
    The subjects will stay in the Study Unit up to two (2) hours after each challenge and a phone call will be given to them 24 hours after each challenge to verify their global status.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Male or female aged from 18 to 45 years.
    · Signed informed consent.
    · Registered, or agreeing to be registered, in the national register of volunteers.
    · Subject with a history of a allergic conjunctivitis for at least 2 years and with a positive allergic skin test ( for grass or ragweed or birch pollen, or cat hair and dander) or with a positive conjunctival allergen challenge within the previous 24 months of visit 1.
    · Presenting with normal ocular examination of both eyes and without any ocular symptom.
    · Subject able to understand the study instructions.
    · Subject willing to comply with the study schedule and treatment
    E.4Principal exclusion criteria
    - History of ocular herpes, retinal detachment, diabetic retinopathy or any retinal disease.
    - History of ocular trauma, infection or inflammation within the last 3 months.
    - Presence of any significant ocular symptom (notably itching > 1).
    - Presence of one of the following abnormalities or pathologies detected at slit lamp examination:
    · Conjunctival hyperaemia (score ³ 1).
    · Any cornea abnormality including presence of at least 5 corneal punctuations stained by fluorescein (score 1b= Fluorescein – stained punctuations < 10% of the corneal surface and ³ 5 and < 10 punctuations).
    · Chemosis (score ³ 1).
    · Tearing (score ³ 1)
    · Folliculo-papillary conjunctivitis (score ³ 1 after inferior and superior eye-lid eversion)· Conjunctival discharge (score ³ 1).
    · Eyelid swelling (score ³ 1).
    · Tyndall > 0
    - History of ocular hypertension
    - Presence of any ocular pathology such as dry-eye syndrome, blepharitis, iritis, uveitis or any other ocular infection.
    - Extended contact lens wear (occasional wear is allowed before the study but not one week before the study or during the study).
    - Known or suspected hypersensitivity to one of the components of the study medication, or to any other antiallergic, topical anaesthetic drugs and/or fluorescein.
    - Current allergic pathology ongoing (i.e., status asthmaticus or moderate to severe allergic asthma)
    - Desensitisation within the past 3 months
    - Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplasic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc… and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study.
    - Current bronchitis.
    - Ongoing tooth care.
    - Recent acute illness with a recovery period within the 2 weeks prior to the inclusion day (Day 0).
    - History of alcohol abuse (alcohol consumption > 50 g/day).
    - Chronic cigarette smoking (≥ 10 cigarettes per day).
    - Past or present history of drug abuse and/or excessive use of medications.

    - Pregnancy, lactation.
    - Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) and is not surgically sterilised.
    - Regular exposure to a smoky environment and/or air conditioning
    - Application of eye make-up during the study
    - Participation in any high-speed, intensive sports or water-sports from Day 0 to Day 21
    - Inability of subject to understand the study procedures and thus inability to give informed consent.
    - Non compliant subject (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
    - Participation in another clinical study within the last 3 months. (Or still during the exclusion period of another clinical study.)
    - Already included once in this study.
    - Ward of court.
    - Patient not covered by the Social Security scheme when existing in the concerned country.
    - Subject has received more than the legal limit of 4 500,00 Euros of compensation for participating in clinical trials during the course of the previous 12 months.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy criteriria, subject's self assessment for itching of each eye 5mn after the CAcC (V2 and V3).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    double masked, intra-individual comparison
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last phone contact with the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-01
    P. End of Trial
    P.End of Trial StatusOngoing
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