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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   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:2006-000653-22
    Sponsor's Protocol Code Number:GART1013
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-08-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-000653-22
    A.3Full title of the trial
    The UK Glaucoma Treatment Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The UK Glaucoma Treatment Study
    A.3.2Name or abbreviated title of the trial where available
    UK GTS
    A.4.1Sponsor's protocol code numberGART1013
    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 SponsorMoorfields Eye Hospital
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationMoorfields Eye Hospital
    B.5.2Functional name of contact pointSue Lydeard
    B.5.3 Address:
    B.5.3.1Street Address162 City Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC1V 2PD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402075662816
    B.5.5Fax number4402076086925
    B.5.6E-mailsue.lydeard@moorfields.nhs.uk
    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 Latanoprost
    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.3.1Product nameXalatan
    D.3.2Product code PhXA41
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    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 placeboEye drops, solution
    D.8.4Route of administration of the placeboIntraocular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary open-angle Glaucoma Pseudoexfoliation Glaucoma
    E.1.1.1Medical condition in easily understood language
    Primary open-angle Glaucoma Pseudoexfoliation 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037118
    E.1.2Term Pseudoexfoliation glaucoma
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary study objectives 1) To evaluate the therapeutic benefit of IOP reduction with Latanoprost on the frequency of VF progression events in glaucoma (Hypothesis: Latanoprost reduces the incidence of VF progression events within 18 months by 50%)
    E.2.2Secondary objectives of the trial
    2) To establish the feasibility of initial observation of patients to identify actual progression rates prior to making treatment decisions 3) To identify and quantify the risk factors for progression 4) To establish treatment protocols based on risk profiling and measurement of identifiable rates of progression 5) To conduct a health economic evaluation of the treatment protocols derived from the study data 6) To validate and further refine trial design based on the measurement of rates of structural and functional progression with quantitative imaging and VF testing 7) To identify and quantify the risk factors for response to treatment 8) To establish the relation of structural and functional measurement in progressing patients 9) To obtain pilot data to compare different forms of quantitative imaging device 10) To compare quantitative imaging devices with the reference standard of optic disc photography
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion criteria a) Newly detected, previously untreated open-angle glaucoma (including primary open-angle glaucoma, normal tension glaucoma and pseudoexfoliation glaucoma) in either eye. Glaucoma is defined as: reproducible glaucomatous visual field (VF) defects in at least one eye with corresponding damage to the optic nerve head (cup disc ratio > or = 0.7 and/or focal narrowing of the neural rim) and in the absence of retinal or neurological condition that may account for the VF loss. A glaucomatous VF is defined as a reproducible defect (in at least 2 consecutive reliable post-screening VFs) of two or more contiguous points with P < 0.01 loss or greater, or three or more contiguous points with P < 0.05 loss or greater, or a 10-dB difference across the nasal horizontal midline at two or more adjacent points in the total deviation plot.36 b) Intraocular pressure: mean (screening and training visit) less than 30mmHg, any IOP <35mmHg c) Age: adult (over 16 years – UK Clinical Trials Regulations 2004) Note: this differs from EMGT where the age range was 50 to 80 years of age d) Snellen visual acuity better than 6/12 e) Able to give informed consent and attend at the required frequency for the duration of the study
    E.4Principal exclusion criteria
    Exclusion criteria a) Moderately advanced visual field loss (mean deviation worse than -10dB in the better eye or worse than -16 dB in the other eye) or a threat to fixation (paracentral point total sensitivity < 10dB) in either eye Note: EMGT had no extra criteria for paracentral points b) Intraocular pressure > 35mmHg on two consecutive occasions in either eye c) Unable to perform reliable visual field testing (<15% false positives, <25% false negatives, <25% fixation losses) d) Unable to provide sufficient quality HRT images (MPHSD <35m) e) Cataractous lens gradings of more than N1, C2, or P1 according to LOCS II f) Previous intraocular surgery (other than uncomplicated cataract extraction with posterior chamber lens implantation) g) Cataract extraction with posterior chamber lens implantation within the last year h) Diabetic retinopathy
    E.5 End points
    E.5.1Primary end point(s)
    Outcomes: The primary outcomes are: 1. Visual field progression within 18 months as defined in the EMGT study – at least 3 test points showing significant progression (on the pattern deviation Glaucoma Change Probability Maps), as compared with baseline, at the same locations on three consecutive occasions
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 Months
    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 Yes
    E.6.4Safety No
    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 Yes
    E.6.12Pharmacoeconomic Yes
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 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
    Study endpoints: 1. IOP > 35mmHg on two successive occasions 2. Visual field progression as defined in the EMGT study. An independent ophthalmologist will confirm whether VF loss is consistent with glaucoma or a non-glaucomatous process (such as vein occlusion, stroke, or age-related macular degeneration). 3. decline of best-corrected visual acuity to below 6/18
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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.1.2.1Number of subjects for this age range: 324
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 324
    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 No
    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 state648
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 648
    F.4.2.2In the whole clinical trial 648
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation University of Aberdeen
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Nolfolk and Norwich University Hospital
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation University of Birmingham
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation University of Manchester
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Glouchester Eye Unit
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Bristol Eye Hospital
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation Sunderland Eye Infirmary
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-19
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