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    Summary
    EudraCT Number:2008-000580-41
    Sponsor's Protocol Code Number:LTG1030-PIV-12/07
    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:2008-03-11
    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 number2008-000580-41
    A.3Full title of the trial
    Safety and Efficacy assessment of Geltim LP ® 1 mg/g (unpreserved Timolol gel – TG1030) in ocular hypertensive or glaucomatous patients stabilized by Xalatan® with ocular intolerance signs
    A.3.2Name or abbreviated title of the trial where available
    GELTIM
    A.4.1Sponsor's protocol code numberLTG1030-PIV-12/07
    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 THEA
    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 Geltim LP ® 1 mg/g (0.1% timolol maleate gel, without preservative) packaged in single-dose containers (unidoses)
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires THEA
    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.3.4Pharmaceutical form Eye gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPConjunctival use (Noncurrent)
    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 Information not present in EudraCT
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Xalatan® (latanoprost 0.005% preserved formulation packaged in multidose container)
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER Holding France
    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.3.4Pharmaceutical form Eye drops*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPConjunctival use (Noncurrent)
    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 Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The main objective is to assess the safety and the efficacy, in intra ocular pressure, of Geltim LP ® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to Prostaglandin eye drops.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018304
    E.1.2Term Glaucoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Ocular tolerance
    Worst eye = most severe eye defined by the highest intolerance score (sum of the score of 8 symptoms + sum of the score of 6 objective signs). In case both eyes are eligible and have the same total intolerance score at D0, the eye with the highest IOP is considered, and if the IOP is the same for both eyes, the right eye is considered.
    •Ocular symptoms (irritation/burning, itching, tearing, stinging upon instillation, eye dryness sensation, foreign body sensation, photophobia, blurred vision)
    •Objective ocular signs (conjunctival hyperaemia, folliculo-papillary conjunctivitis, SPK, blepharitis, interpalpebral conjunctival staining, BUT)

    Efficacy on the IOP
    •The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of the mean basal IOP after a 12 weeks treatment period (84 days ±7)
    E.2.2Secondary objectives of the trial
    Other tolerance criteria
    •Global discomfort assessed by the patient with a Visual Analogue Scale (VAS)
    •The sum of the score of 8 ocular symptoms and the score of each ocular symptoms
    •The sum of the score of 6 objective signs and the score of each objective signs
    •Funduscopy
    •Global local tolerance assessed by the Investigator.
    •Global local tolerance assessed by the patient
    •Number of associated eye drops treatments + evolution of their dose regimen
    •Other ocular AE reporting
    •Systemic AE reporting

    Efficacy on the IOP
    •Comparison between the 2 study products of the mean basal IOP after a 4 weeks treatment period (28 days ± 3 days)
    •Global efficacy assessed by the investigator.
    •Number of withdrawals for therapeutic failure
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be eligible for inclusion in this study if all these criteria are respected:
    -Male or female aged from 18 to 90 years old.
    -Written informed consent.
    -Association of the 4 following criteria:
    1 – Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day).
    2 – IOP ≤ 18 mm Hg in BOTH eyes
    3 – With local intolerance signs in at least one eye defined by the association of:
    3.1-Presence of at least 2 symptoms with a level of severity ≥ 1 (= mild or moderate or severe) among the following 8 symptoms: irritation / burning, itching, tearing, stinging upon instillation, eye dryness sensation, foreign body sensation, photophobia, blurred vision,
    and
    3.2-Presence of at least 1 objective sign among the following:
    •Hyperaemia = Grade (3) or (4) or (5) following McMonnies scale
    •Superficial Punctate Keratitis (SPK) (Grade 1 or 2)
    •Inter-palpebral conjunctival stainings (Grade 1 or 2)
    •Folliculo papillary conjunctivitis (Grade 1 or 2)
    •Blepharitis (Grade 1 or 2)
    •BUT < 10 sec
    E.4Principal exclusion criteria
    Ophthalmic non inclusion criteria in either eye
    Patients fulfilling at the inclusion visit ONE OR MORE of the following non inclusion criteria will not be included in the study:
    -Presence of at least one severe objective sign among the following:
    •Hyperaemia (Grade 6)
    •Superficial Punctate Keratitis (Grade 3)
    •Inter-palpebral conjunctival stainings (Grade 3)
    •Folliculo papillary conjunctivitis (Grade 3)
    •Blepharitis (Grade 3)
    -Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma)
    -Absolute defect in the ten degrees central point of the visual field.
    -Best far corrected visual acuity ≤ 1/10.
    -Aphakia after cataract surgery with no IOL (Intra-Ocular Lens).
    -History of traumatism, infection, inflammation within the 3 months before inclusion visit.
    -Severe on-going ocular allergy.
    -Severe dry eye (defined by severe epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations / day).
    -Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination.
    -Visual field not performed or not available within the 6 months before inclusion visit.
    -Risk of visual field worsening as a consequence of participation in the trial according to the investigator’s best judgement.
    Systemic/non ophthalmic/ non inclusion criteria
    -Absolute contraindications for timolol maleate:
    •Hypersensitivity to timolol maleate, to other beta-blockers or to any component of the drug product,
    •Asthma, chronic obstructive lung disease, history of asthma, bronchial hyperreactivity and severe allergic rhinitis,
    •Cardiac insufficiency unsatisfactorily controlled by the treatment,
    •Cardiogenic shock,
    •Second and third degree atrioventricular blocks in the absence of a pacemaker,
    •Prinzmetal’s angina,
    •Sinus disease (including sinoatrial block),
    •Bradycardia (< 45 to 50 beats per minute),
    •Raynaud’s disease and peripheral circulatory disturbances,
    •Untreated pheochromocytoma,
    •Hypotension
    •Corneal distrophia
    -Non-controlled diabetic patient
    -Known or suspected hypersensitivity to one of the components of the study medication
    -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.
    Specific non-inclusion criteria for female patients
    -Pregnancy, lactation.
    -Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, patch).
    OR
    -Women not hysterectomised, menopaused or surgically sterilized

    Non-inclusion criteria related to general conditions
    -Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent
    -Non compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
    -Participation in another clinical study.
    -Already included once in this study
    -Ward of court.
    -Patient not covered by the Social Security scheme

    Non-inclusion criteria related to previous and concomitant medications / non-product therapies.
    Patient using any of the following previous and concomitant medication / treatment (according to the described periods) will not be included in the study:
    CONCOMITANT MEDICATIONS / NON PRODUCT THERAPIES NOT ALLOWED BEFORE AND DURING THE STUDY
    12 months before inclusion until the end of the study : Filtration surgery for glaucoma, Laser procedure for glaucoma,
    6 months before inclusion until the end of the study, Other ophthalmic surgery or laser procedure (including LASIK or PRK)
    1 month before inclusion until the end of the study :MAOI treatments, Association with floctafenin (Idarac®), sultoprid (Sultopride Panpharma®), amiodarone (Amiodarone [Bayer®, Biogaran®, EG®, GNR®, Merk®, MSD®, Ratiopharm, Systemic anti-glaucoma treatments, Any change in dose regimen for systemic treatments which can have a substantial effect on IOP: Beta-adrenergic blocking and agonist agents, Alpha agonists and blockers, Angiotensin converting enzyme inhibitors, Angiotensin II inhibitors, Calcium channel blockers, Diuretics, Corticoïds
    1 week before inclusion until the end of the study : Any change in dose regimen for other systemic treatments, Any topical ocular treatments (except long term free preservative lachrymal substitutes and/or free preservative anti-allergic eye drops)
    From inclusion until the end of the study : Contact lenses wear
    E.5 End points
    E.5.1Primary end point(s)
    This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP ® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned120
    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 visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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) Yes
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state466
    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 Decision2008-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-02
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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