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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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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    EudraCT Number:2009-012304-55
    Sponsor's Protocol Code Number:192024-038
    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:2009-05-22
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2009-012304-55
    A.3Full title of the trial
    A One Year, Multicenter, Double-Masked, Randomized, Parallel-Group Study Assessing the Safety and Efficacy of Once Daily Application of Bimatoprost 0.03% Solution Compared to Vehicle to Treat Hypotrichosis of the Eyelashes from Varied Etiologies.
    A.3.2Name or abbreviated title of the trial where available
    Bimatoprost for Hypotrichosis of the Eyelashes
    A.4.1Sponsor's protocol code number192024-038
    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 SponsorAllergan Ltd
    B.1.3.4CountryUnited Kingdom
    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.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. name LUMIGAN 0.3 mg/ml eye drops, solution
    D. 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 nameBimatoprost
    D.3.2Product code AGN 192024 - formulation 9106X
    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 IMPTopical 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    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 placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypotrichosis of the eyelashes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10021126
    E.1.2Term Hypotrichosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and efficacy of bimatoprost 0.03% solution once daily bilateral application to the upper eyelid margins compared with vehicle in increasing overall eyelash prominence in subjects exhibiting hypotrichosis of the eyelashes from varied etiologies.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects at least 18 years of age

    2. For post chemotherapy subjects, the following criteria will be verified by the investigator, including using the subject's prior medical history obtained from the subject's attending oncologist:
    a. Subject reports chemotherapy induced eyelash hypotrichosis
    b. Treated for solid tumor type stage 1 or stage 2 cancer with a curative intent, i.e. received standard adjuvant therapy for breast or colorectal cancer, or received front-line therapy for diffuse larger-cell lymphoma or Hodgkin's lymphoma.
    c. All side effects and serious side effects related to chemotherapy treatment are resolved with the exception of hair loss, e.g. hematology and liver function test results are within the range acceptable to the oncologist and investigator; any other chemotherapy induced effects such as oral mucositis, eye irritation, or skin rash or discoloration have resolved.
    d. Completed their course of chemotherapy treatment at least 4 weeks but no more than 12 weeks prior to baseline.
    e. No evidence of metastases, and not anticipated to receive further chemotherapy during the course of the study
    f. ECOG score of 0 or 1
    g. Anticipated to be well enough to complete the study

    3. Written informed consent has been obtained prior to any study-related procedures

    4. Written Authorization for Use and Release of Health and Research Study Information (US sites only) or Data Protection Consent (European sites only) has been obtained.

    5. A score of 1 or 2 on the Glibal Eyelash Assessment (GEA)

    6. A score of 1 or 2 on each of 3 items (16, 19, and 18) on the PRO questionnaire

    7. A best-corrected visual acuity score equivalent to a Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet

    8. Intraocular pressure (IOP) ≤ 20 mm Hg in each eye

    9. Female subjects of childbearing potential must have a negative urine pregnancy test at Day 1 prior to receiving study medication. A woman is considered NOT to be of childbearing potential if she either is post menopausal with at least 12 consecutive months of amenorrhea or has no uterus.

    10. Ability to follow study instructions and willingness to complete all required procedures and visits.

    E.4Principal exclusion criteria
    1. Any uncontrolled systemic disease

    2. Subjects with unequal right and left GEA scores

    3. Subjects with any known disease or abnormality of the lids, lashes, ocular surface, or lacrimal duct system

    4. Subjects with alopecia areata or scarring alopecia of the eyelid including lid tumors, herpes zoster, and other eyelid skin scarring diseases

    5. Subjects with known or suspected trichotilomania disorder

    6. Any ocular pathology in either eye that may interfere with the ability to obtain accurate IOP readings

    7. Contraindications to pupil dilation

    8. Active ocular disease (e.g. glaucoma, uveitis, ocular infections, ocular tumor, severe dry eye, or chronic blepharitis); myopia, hyperopia, presbyopia, strabismus, and cataracts are allowed provided other study criteria are met

    9. Any ocular or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to baseline or any anticipated need for ocular surgery for the duration of the study

    10. Subjects unwilling or unable to remove contact lenses prior to study medication application in the evening and keep lenses out for at least 30 minutes following application

    11. Any permanent eyeliner or eyelash implants of any kind

    12. Any semi-permanent eyelash tint, dry, or eyelash extension application within 3 months prior to baseline; daily use of removable eyeliner and mascara is allowed provided other study criteria are met

    13. Any use of over-the-counter eyelash growth products within 6 months prior to baseline

    14. Any use of prescription eyelash growth products (i.e. LATISSE™ in US)

    15. Treatments that may affect hair growth (e.g., minoxidil, Propecia®, etc) within 6 months prior to baseline, except for prior chemotherapy in the post chemotherapy subject population.

    16. Any required use of IOP-lowering eye drops such as prostaglandin or prostamide, or prescription medications for dry eye at baseline, or anticipated use of these treatments during the study; OTC artificial tears or lubricants are allowed

    17. Known allergy or sensitivity to the study medication, its components, or eye make-up remover used in the study
    18. Subjects with mascular edema or those who are aphakic, pseudophakic with a torn posterior lens capsule, or subjects having known risk factors for macular edema

    19. Females who are pregnant, nursing, or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception

    20. Current enrolment in an investigational drug or device study or participation in such a study within 30 days prior to baseline and previous enrolment in any Allergan sponsored bimatoprost clinical studies

    21. Investigational site staff and/or their relatives

    22. Subject has a condition or is in a situation which, in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subjects participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    Bimatoprost 0.03% solution and vehicle are equally effective in increasing eyelash prominence as measured by the proportion of treatment responders at month 4, a composite endpoint defined by 1) at lease a 1-grade improvement from baseline in the 4-point GEA scale and 2) at least a 3-point improvement from baseline in the total score for domain 2 of a PRO questionnaire
    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. 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) No
    E.8.2.2Placebo Yes
    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 concerned9
    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 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
    The end of the trial will be the last subject last visit.
    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 months6
    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 months6
    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 Yes
    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 state348
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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)
    Volunteers care will be by the study doctor in accordance with the treatments provided by the PIs local hospital.
    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 Decision2009-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-10
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