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    Summary
    EudraCT Number:2012-002078-30
    Sponsor's Protocol Code Number:RDG-11-244
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-07
    Trial results View 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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2012-002078-30
    A.3Full title of the trial
    Assessing the Efficacy and Tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative (travoprost 0.004%) versus LUMIGAN® 0.01% Solution with BAK (bimatoprost 0.01%) in Treatment Naïve patients with Ocular Hypertension or Open Angle Glaucoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy and tolerability of Travatan and Lumigan in patients with ocular hypertension or glaucoma but who never received any glaucoma drugs.
    A.4.1Sponsor's protocol code numberRDG-11-244
    A.5.4Other Identifiers
    Name:Not availableNumber:Not available
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlcon Research, Ltd.
    B.1.3.4CountryUnited States
    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 supportAlcon Research, Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDokumeds Ltd
    B.5.2Functional name of contact pointRasa Ziliuviene
    B.5.3 Address:
    B.5.3.1Street AddressAlojas 6
    B.5.3.2Town/ cityRiga
    B.5.3.3Post codeLV-1013
    B.5.3.4CountryLatvia
    B.5.4Telephone number37052101449
    B.5.5Fax number37052101450
    B.5.6E-mailRasa.Ziliuviene@Dokumeds.com
    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 TRAVATAN
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories (UK) Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTRAVATAN
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 157283-68-6
    D.3.9.3Other descriptive nameTRAVOPROST
    D.3.9.4EV Substance CodeSUB12613MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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 LUMIGAN
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLUMIGAN
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    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 INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ocular hypertension or Open angle glaucoma
    E.1.1.1Medical condition in easily understood language
    Ocular hypertension and glaucoma.
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to assess the efficacy and tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative versus LUMIGAN® 0.01% Solution in treatment naïve patients with ocular hypertension or open angle glaucoma.
    E.2.2Secondary objectives of the trial
    For the secondary analysis, changes in the following study variables will be assessed: Ocular Hyperemia grading, Tear Film Break Up Time, Ocular Surface Disease Index (OSDI), Ocular Staining (before and after 6 months of PGA therapy) and the percentage of patients who reach target IOP (≤18 mmHg) after 6 months of PGA therapy. The following exploratory variables will also be evaluated: Assessing both conjunctival epitheliai cells and goblet cells in impression cytology specimens before and after 6 months of PGA therapy and Assessing the expression of both HLA-DR (an inflammatory marker) and MUC5AC (a protein found in goblet cells) in impression cytology specimens by flow cytometry before and after 6 months of PGA therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must be at least 18 years of age.
    2. Must be diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
    3. Must have an IOP between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
    4. Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
    5. Must have a baseline a tear film break up time (TBUT) of ≥ 5 seconds.
    6. Must have a baseline ocular staining grade of < III (i.e. between 0 and II) based on Oxford scale.
    7. In case one eye is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
    8. Must be able to follow instructions and be willing and able to attend all study visits.
    9. Must have best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
    10. An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
    E.4Principal exclusion criteria
    1. Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
    2. Any abnormality preventing reliable applanation tonometry in either eye.
    3. Corneal dystrophies in either eye.
    4. Any opacity or patient uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
    5. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
    6. History of severe dry eye, keratoconjunctivitis sicca, ocular pemphigoid or Stevens-Johnson syndrome.
    7. Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
    8. History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications)
    9. Contact lens wearers are excluded
    10. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
    11. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
    12. Progressive retinal or optic nerve disease from any cause.
    13. A history of, or at risk for uveitis or cystoid macular edema (CME).
    14. Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
    15. Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control must have been used for at least one month prior to Visit 1 and is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
    16. Women who are pregnant or lactating
    17. Unwillingness to risk the possibility of darkened iris or eyelash changes.
    18. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
    19. Participation in any other investigational study within 30 days prior to the Screening Visit.
    E.5 End points
    E.5.1Primary end point(s)
    Mean Change in IOP from baseline between both treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3 and Month 6 visits.
    E.5.2Secondary end point(s)
    Change in Ocular Hyperemia grading after 6 months of PGA therapy between both treatment groups; Change in Ocular Surface Disease Index after 6 months of PGA therapy between both treatment groups; Change in tear film break up time (after 6 months of PGA therapy) between both treatment groups; Change in ocular staining (after 6 months of PGA therapy) between both treatment groups Percentage of patients who reach target IOP (≤ 18 mmHg) between both treatment groups. An interim analysis of all study variables will be conducted at the 3 month visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 3 and Month 6 visits.
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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 No
    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
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 104
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard therapy, no differences from the normal treatment
    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 Decision2012-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-18
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