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    The EU Clinical Trials Register currently displays   43974   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:2012-001324-34
    Sponsor's Protocol Code Number:C-12-008
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-02-15
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2012-001324-34
    A.3Full title of the trial
    A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Travoprost 0.004% in Pediatric Glaucoma Patients
    A.3.2Name or abbreviated title of the trial where available
    Travoprost 0.004% in Pediatric Glaucoma Patients
    A.4.1Sponsor's protocol code numberC-12-008
    A.7Trial is part of a Paediatric Investigation Plan Yes
    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 organisationAlcon Eye Care UK Limited
    B.5.2Functional name of contact pointHead of EURMEA Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressFrimley Business Park, Frimley
    B.5.3.2Town/ cityCamberley, Surrey
    B.5.3.3Post codeGU16 7SR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4401276673389
    B.5.6E-mailzubair.hussain@alconlabs.com
    D. IMP Identification
    D.IMP: 1
    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 TIMOLOL MALEATE Ophthalmic Solution USP, 0.25%
    D.2.1.1.2Name of the Marketing Authorisation holderFalcon Pharmaceuticals, Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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 INNTimolol
    D.3.9.1CAS number 26921-17-5
    D.3.9.3Other descriptive nameTIMOLOL
    D.3.9.4EV Substance CodeSUB11069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 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 TIMOLOL MALEATE Ophthalmic Solution USP, 0.5%
    D.2.1.1.2Name of the Marketing Authorisation holderFalcon Pharmaceuticals, Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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 INNTimolol maleate
    D.3.9.3Other descriptive nameTIMOLOL
    D.3.9.4EV Substance CodeSUB11069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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: 3
    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 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.3.8INN - Proposed INNtravoprost
    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 % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.004
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEar drops, solution
    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
    Pediatric glaucoma;elevated intraocular pressure
    E.1.1.1Medical condition in easily understood language
    Glaucoma
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    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 objective of this study is to demonstrate that the IOP-lowering efficacy of Travoprost Ophthalmic Solution, 0.004% (preserved with POLYQUAD) is noninferior to Timolol Ophthalmic Solution (0.5% or 0.25%) in pediatric glaucoma patients.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients 2 months to <18 years of age
    2. Diagnosis of pediatric glaucoma
    3. Patients with conditions requiring chronic treatment with glucocorticoids resulting in steroid induced glaucoma may be enrolled as long as the patient has been on a stable dose of steroids for at least 30 days prior to the Screening Visit.
    4. Qualifying mean IOP at the Eligibility Visit in at least one eye must be:
    • ≥ 20 mmHg at the 9 AM (± 60 minutes) time point
    Note: Mean IOP is the average of 2 successive IOP measurements in the same eye, as described in the Manual of Procedures. A third measurement is required if the first 2 measurements differ by more than 4 mmHg.
    5. Aphakic patients with contact lenses may be enrolled. If study drops are to be instilled with lens in place, patient will be
    provided with a contact lens to be used during the study.
    6. Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized
    representative prior to any procedure specified in the protocol, including screening procedures.
    E.4Principal exclusion criteria
    1. Females of childbearing potential are excluded from participation in the study if they meet any of the following conditions:
    a. They are currently pregnant
    b. They have a positive result on a pregnancy test at the Screening Visit
    c. They intend to become pregnant during the study period
    d. They are breast feeding
    e. They are not using any of the following highly effective birth control measures:
    • True abstinence – when this is in line with the preferred and usual lifestyle of the subject. If subjects become sexually active, they must agree to use one of the birth control methods (hormonal, mechanical, or
    surgical) listed below for the remainder of the study.
    • Hormonal – implanted contraceptives.
    • Mechanical –IUD with progestogen.
    • Surgical – vasectomized partner (must be ≥ 6 months post vasectomy).
    Note: All females of childbearing potential must consent to a urine pregnancy test at the Screening Visit and upon exiting the study.
    Note: Females of childbearing potential will be instructed to immediately inform the Investigator if they become pregnant during the study. Should this occur, the
    Investigator shall immediately contact the Sponsor).
    2. Patients who have previously failed long-term treatment with a prostaglandin analog or timolol to control IOP or patients in
    which reasonable IOP control would not be expected from pharmacological treatment.
    3. History of chronic, recurrent or severe inflammatory eye disease (ie, scleritis, uveitis, herpes keratitis).
    4. Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
    5. Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
    6. Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in the study eye.
    7. Severe ocular pathology (including severe dry eye) in the opinion of the Investigator that would preclude the
    administration of a topical prostaglandin analog or a topical beta-blocker.
    8. Intraocular surgery within the past 30 days in the study eye prior to the Screening Visit.
    9. Any abnormality preventing reliable applanation tonometry, including a history of penetrating keratoplasty.
    10. Patients with a history of previous cyclodestructive procedure.
    11. Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable
    for the study.
    12. Hypersensitivity to any component of the study medications, including medications administered during study exams, in the opinion of the Investigator.
    13. History of congenital cardiovascular anomalies or abnormalities which would preclude the safe administration of
    a topical beta-blocker. In the event that the effects of the study medications are unclear, the patient may participate with
    written approval from the patient’s cardiologist.
    There is a potential for additive effects resulting in hypotension and/or marked bradycardia when eye drops with
    timolol are administered concomitantly with oral calcium channel blockers, quanethidine or beta-blocking agents, antiarrhythmics,
    digitalis glycosides or parasympathomimetics.
    The hypertensive reaction to sudden withdrawal of clonidine or can be potentiated when taking beta-blockers. Potentates systemic beta-blockade (e.g. decreased heart rate) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, cimetidine) and timolol. Beta-blockers may increase the hypoglycemic effect of anti-diabetic agents.
    Beta-blockers can mask the signs and symptoms of hypoglycemia.
    Investigators must use their clinical judgment regarding the use of these products during the study.
    14. Use of any additional topical or systemic ocular hypotensive medication during the study.
    15. Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding the IOP-lowering
    treatments) or substances administered by any route and used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents). The dosing regimen of these medications should not change during the study.
    16. Therapy with another investigational agent or device within 30 days prior to the Screening Visit.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy
    • IOP change from baseline at Month 3
    Secondary Efficacy
    • Not applicable
    Supportive Efficacy
    • IOP change from baseline at Week 2 and Week 6
    • IOP and IOP percent change from baseline at each visit (Week 2, Week 6, and Month 3)
    • Percentage of patients who achieve at least a 15% reduction at each visit (Week 2, Week 6, and Month 3)
    • Percentage of patients who reach an IOP within a normal range
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2, Week 6 and Month 3
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    Colombia
    France
    Germany
    India
    Mexico
    Peru
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Saudi Arabia
    Singapore
    Spain
    Taiwan
    Ukraine
    United Kingdom
    United States
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 130
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 65
    F.1.2Adults (18-64 years) No
    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 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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 130
    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)
    Not different from the expected normal treatment for the condition.
    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 Decision2013-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-25
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