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    The EU Clinical Trials Register currently displays   43973   clinical trials with a EudraCT protocol, of which   7311   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:2009-010606-10
    Sponsor's Protocol Code Number:C-09-001
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-08
    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 ConcernedLatvia - SAM
    A.2EudraCT number2009-010606-10
    A.3Full title of the trial
    An Evaluation of Patient Reported Outcomes and Ocular Surface Health in Patients Using Travoprost APS Eye Drops Solution Versus XALATAN Eye Drops Solution
    A.3.2Name or abbreviated title of the trial where available
    Travoprost APS versus XALATAN in OSDI
    A.4.1Sponsor's protocol code numberC-09-001
    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 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 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 No
    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 nameTravoprost APS
    D.3.2Product code NA
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRAVOPROST
    D.3.9.1CAS number 157283-68-6
    D.3.9.2Current sponsor codeAL-6221
    D.3.9.3Other descriptive nameTRAVOPROST
    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) 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.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
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLATANOPROST
    D.3.9.1CAS number 130209824
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Open Angle Glaucoma or Ocular Hypertension
    MedDRA Classification
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10030348
    E.1.2Term Open angle glaucoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary statistical objective is to describe differences between Travoprost APS and XALATAN® for mean NEI VFQ-25 composite (Visual Function) score at the end of the three-month treatment period in patients with open-angle glaucoma or ocular hypertension.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients must meet the following criteria:
    1. Patients ≥ 18 years of age.
    2. Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one eye.
    3. Must have a corneal fluorescein staining score of ≥ 1 in at least one eye
    Note: If the patient is currently dosing with XALATAN® in only one eye, the eye being dosed must be the one with corneal staining. If the patient is currently dosing both eyes, staining must be present in at least one eye. Scoring should be based on staining that is, in the opinion of the investigator, typical of staining found in patients with chronic use of preserved eye drops.
    4. Must have had their IOP controlled with mono-therapy using latanoprost 50 micrograms/ml eye drops (XALATAN®) for at least 1 continuous month immediately prior to Visit 1.
    5. The intraocular pressure should be able to be controlled in the opinion of the Investigator and stable while on mono-therapy with the study medication for the eye(s) currently being dosed with XALATAN®.
    6. Must have an intraocular pressure in both eyes that, in the opinion of the Investigator, is considered to be stable and safe for the patient.
    7. The last dose of XALATAN® must have been instilled the evening prior to Visit 1.
    8. Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
    NOTE: This includes discontinuation of any artificial tears.
    9. Best-corrected visual acuity score of ≥ 55 ETDRS in each eye (see Section 18.1.2. for details on the procedure).
    10. Women of childbearing potential must meet all of the following conditions at Visit 1:
    • They are not breast-feeding.
    • They have a negative urine pregnancy test at Visit 1.
    • They agree to undertake a urine pregnancy test upon entering and exiting the study.
    • They are not planning to become pregnant during the course of the study.
    • They are currently using, and agree to continue to use adequate birth control methods for the duration of the study. Adequate birth control methods are defined as:
    Hormonal: oral, implantable, topical, or injectable contraceptives
    Mechanical: IUD, spermicide in conjunction with a barrier such as condom or diaphragm
    Surgical: sterilization of partner and / or self
    Abstinence: If patients become sexually active, they must agree to use one of the birth control methods (hormonal, mechanical, or surgical) listed above.
    E.4Principal exclusion criteria
    Patients demonstrating any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study, or that may in the opinion of the Investigator, affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude patients from enrollment in this study:
    1. Any abnormality preventing reliable applanation tonometry in the study eye(s).
    2. Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
    3. Dry eye or KCS currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
    4. Patients with suspected or diagnosed Sjogren’s syndrome currently being treated with with punctal plugs, punctal cautery, other topical ocular medications or the use of systemic therapy (e.g., RESTASIS® or EVOXAC®).
    5. Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit 1.
    6. Any other ocular laser surgery in either eye within 3 months prior to Visit 1.
    7. Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
    8. History of progressive retinal or optic nerve disease other than glaucoma.
    9. Severe central visual field loss in either eye based upon the clinical judgment of the investigator. For Humphrey and Octopus perimeters severe central visual field loss is defined as a sensitivity of less than or equal to 10 dB in at least two (2) of the four (4) visual field test points closest to the point of fixation.
    10. Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye. These conditions may include, but are not limited to:
    • Clinically significant blepharitis (requiring pharmacological treatment) within 3 months prior to Visit 1.
    NOTE: Non-clinically significant (does not require pharmacological treatment) or prostaglandin-induced conjunctival injection and blepharitis are allowed.
    • Rosacea affecting the eye adnexa and its ocular sequelae (i.e., hordeola, chalazion, recurrent meibomian gland dysfunction);
    • Clinically significant corneal dystrophies (defined as affecting the structure of the corneal surface or best corrected visual acuity, or is an actively changing or unstable condition);
    • History of chronic or recurrent inflammatory eye diseases (e.g., uveitis, scleritis, herpes keratitis, iritis, etc);
    11. Ocular trauma within 6 months prior to Visit 1 in either eye, as determined by patient history and/or examination.
    12. Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
    NOTE: During the course of the 90-day study, short-term use of certain
    over-the-counter medications for such ailments as headache, cough, gastrointestinal upset, diarrhea, arthritis, etc., will be allowed, provided that these medications, in the opinion of the Investigator, will not substantially alter the integrity of the ocular surface during the study. The use of certain migraine medications such as sumatriptan succinate, rizatriptan benzoate, naratriptan hydrochloride, etc., is permitted during the course of the study. Advice from the Medical Monitor should be sought if there is any question regarding the use of concomitant medication.
    13. Use of ocular medications (including over the counter and prescription medications) other than XALATAN® within 7 days of Visit 1.
    Note: Use of over-the-counter artificial tears up to the time of Visit 1 is allowed.
    14. Use of corticosteroids within 30 days of Visit 1, or any anticipated use of corticosteroids during the course of the study.
    Note: Inhaled bronchial dilators containing a steroid component are acceptable provided that they are used at a stable dosing regimen for at least 30 days prior to Visit 1.
    15. Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.
    16. History of intolerance or hypersensitivity to any component of the test articles.
    17. Participation in an investigational drug or device study within 30 days of entering this study.
    18. History or evidence of corneal transplant or transplant variant procedures [Descemet’s stripping endothelial keratoplasty (DSEK), Descemet’s stripping endothelial automated keratoplasty (DSAEK), lamellar keratoplasty, etc.].
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is mean VFQ-25 composite (Visual Function) score at the end of the treatment period (Day 90). A two-sample t-test will be used to test for differences between treatments in the means.
    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) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    XALATAN
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 296
    F.4.2.2In the whole clinical trial 516
    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 Decision2009-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
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