Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-001528-41
    Sponsor's Protocol Code Number:PG324-CS303
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-03-01
    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 number2015-001528-41
    A.3Full title of the trial
    A prospective, double-masked, randomized, multicenter, active-controlled, parallel-group, 6-month study assessing the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution compared to GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic Solution in subjects with elevated intraocular pressure (MERCURY 3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective, double-masked, randomized, multicenter, active-controlled, parallel-group, 6-month study assessing the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution compared to GANFORT® (bimatoprost 0.03% / timolol 0.5% Opthalmic Solution) in subjects with elevated intraocular pressure (MERCURY 3)
    A.3.2Name or abbreviated title of the trial where available
    MERCURY 3
    A.4.1Sponsor's protocol code numberPG324-CS303
    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 SponsorAerie Pharmaceuticals Ireland Ltd.
    B.1.3.4CountryIreland
    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 supportAerie Pharmaceuticals Ireland Ltd.
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAerie Pharmaceuticals Ireland Ltd.
    B.5.2Functional name of contact pointFinbar O’Neill
    B.5.3 Address:
    B.5.3.1Street AddressPembroke House , 28-32 Pembroke Street Upper
    B.5.3.2Town/ cityDublin 2
    B.5.3.3Post codeD02EK84
    B.5.3.4CountryIreland
    B.5.4Telephone number+35387 632 8837
    B.5.6E-mailMercury3@aeriepharma.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 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 nameRoclatan
    D.3.2Product code PG324
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLatanoprost
    D.3.9.1CAS number 130209-82-4
    D.3.9.2Current sponsor codePG324
    D.3.9.3Other descriptive nameLATANOPROST
    D.3.9.4EV Substance CodeSUB08409MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.005
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNetarsudil
    D.3.9.1CAS number 1422144-42-0
    D.3.9.2Current sponsor codePG324
    D.3.9.3Other descriptive nameNETARSUDIL
    D.3.9.4EV Substance CodeSUB186855
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.02
    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 GANFORT®
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland Ltd
    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 nameGANFORT®
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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 number0.3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOL
    D.3.9.1CAS number 26839-75-8
    D.3.9.4EV Substance CodeSUB11069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Open angle glaucoma (OAG) or ocular hypertension (OHT)
    E.1.1.1Medical condition in easily understood language
    Open angle glaucoma (OAG) or ocular hypertension (OHT)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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
    To evaluate:
    The ocular hypotensive efficacy of PG324 Ophthalmic Solution relative to GANFORT® Ophthalmic
    Solution at 08,00,10:00 and 16:00 hours at Week 2, Week 6 and Month 3.
    E.2.2Secondary objectives of the trial
    To evaluate:
    • The ocular and systemic safety of PG324 Ophthalmic Solution relative to GANFORT® Ophthalmic solution over a 6-month period.
    • Change in Self-Administered National Eye Institute ( NEI) Visual Functioning Questionnaire 25 (VFQ 25) score from baseline to study exit for PG324 compared to GANFORT®.
    • Change in self-administered Short Form Health Survey Questionnaire 36 (SF-36 v2) score from baseline to study exit for PG324 compared to GANFORT®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects have to meet all of the following criteria at screening and qualification visits to enter into the study:
    1. Must be 18 years of age or older
    2. Diagnosis of OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is acceptable)
    3. Subjects insufficiently controlled and/or subjects considered in need for combination therapy by the investigators
    4. Medicated intraocular pressure ≥ 17mmHg in at least one eye and < 28mmHg in both eyes at the screening
    visit.
    5. Unmedicated (post-washout) IOP > 20mmHg in at least one eye and < 36mmHg in both eyes at 2
    qualification visits at 08:00 hour, 2-7 days apart. At the second qualification visit, have IOP > 17mmHg in
    at least one eye and < 36mmHg in both eyes at 10:00 and 16:00 hours. Note: For purposes of determining
    eligibility of subjects to be enrolled the non–integral IOP mean number will be used. Any non-integral
    mean IOP number should not be rounded. If only one eye qualifies at the second qualification visit it
    MUST be the same eye that qualified on the first visit and this will be the study eye for the duration
    of the study.
    6. Best corrected visual acuity +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200 or better Snellen visual acuity in each eye)
    7. Be able and willing to give signed informed consent and follow study instructions
    8. Women must be either of non-child bearing potential, or women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
    9. Women of child bearing potential must have a negative urine pregnancy test within 7 days of first dose of study treatment and agree to use highly effective contraception during the study and for 3 months after the last dose of study medication
    10. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective form of contraception from time of randomization and for 3months following the last dose of study medication.
    11. In France, a subject will be eligible for inclusion in this study only if either affiliated to or as a beneficiary of a social security number
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria during screening or qualification evaluations (e.g., at the time of randomization) will be excluded from entry into the study:

    Ophthalmic:
    1. Clinically significant ocular disease (e.g. corneal edema, uveitis, or severe keratoconjunctivitis sicca)
    which might interfere with interpretation of the study efficacy endpoints or with safety assessments,
    including subjects with glaucomatous damage so severe that washout of ocular hypotensive medications for 4 weeks or longer if needed is not judged safe as it would put the subject at risk for further vision loss.
    2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles (i.e., Grade 2 Shaffer (Chan Ry 1981) or less; extreme narrow angle with complete or partial closure). Note: Previous laser peripheral iridotomy is NOT acceptable
    3.Intraocular pressure ≥ 36mmHg (unmedicated) in either eye (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combination medications, for the purpose of this exclusion criterion, count as one medication. However, subjects currently taking 2 fixed dose combination products are excluded.
    4. Treatment-naïve subjects
    5. Prior treatment with GANFORT® topical eye drops where the subjects IOP did not achieve the target IOP
    and was considered either a therapeutic failure or to have insufficient response. Subjects currently
    (immediately prior to screening visit) being treated with GANFORT® are excluded from the study.
    6. Known hypersensitivity to any component of the investigational formulations to be used (e.g., benzalkonium chloride etc.) or to fluorescein
    7. Previous glaucoma intraocular surgery, including SLT or ALT in either eye.
    8. Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal cross-linking, keratoplasty)
    9. Ocular trauma within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening
    10. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, current evidence or history of herpes simplex or zoster keratitis in either eye at screening.
    11. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications which must have been the same medication for 30 days prior to screening (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study) as prescribed by the Investigator.
    12. Mean central corneal thickness greater than 620μm at screening
    13. Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g., keratoconus)
    Systemic:
    14. Clinically significant abnormalities in laboratory tests at screening
    15. Known hypersensitivity or contraindication to GANFORT® (Appendix 3 Marketed Product Medication
    Information Section 4.3) and to β-adrenoceptor antagonists (e.g. Chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third-degree heart block or congestive heart failure; cardiac failure, cardiac shock and severe diabetes).
    16. Clinically significant systemic disease which might interfere with the study
    17. Participation in any investigational study within 30 days prior to screening
    18. Systemic medication including corticosteroid containing drugs that could have a substantial effect on IOP
    which HAVE NOT been maintained at a consistent dose and regime within 30 days prior to screening and
    are anticipated to change in dose and/or regimen during the study.
    19. Use of topical steroid containing medications on the face or in or around the eyes will exclude the subject
    (see section 5.6 concomitant medications).
    20. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a
    medically acceptable and highly effective form of birth control. An adult woman is considered to be of
    childbearing potential unless she is one year post-menopausal (1 year without menses with appropriate
    clinical profile, e.g. age appropriate, > 45 years in the absence of HRT. In questionable cases the subject
    must have FSH value > 40mIU/mL and an estradiol value < 40pg/mL (< 140pmol/L)) or three months
    post-surgical sterilization.
    21. Vulnerable subjects such as minors, adults under legal protection or unable to express their consent (e.g. hospitalized persons in coma), persons deprived of liberty (prisoners from jails), or persons subject to psychiatric care.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome will be comparison of PG324 Ophthalmic Solution relative to GANFORT® for:
    • Mean IOP within a treatment group at the following time points: 08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 study visits.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy endpoint of mean IOP to be evaluated at 08:00, 10:00 and 16:00 hours at the Week 2, Week 6 and Month 3 study visits.
    E.5.2Secondary end point(s)
    Secondary efficacy outcomes will be comparison of PG324 Ophthalmic Solution relative to GANFORT® for:
    • Mean diurnal IOP within a treatment group at each post-treatment visit.
    • Mean change from diurnally adjusted baseline IOP at each post-treatment time point.
    • Mean change from baseline in diurnal IOP at each post-treatment visit.
    • Mean percent change from diurnally adjusted baseline IOP at each post-treatment time point.
    • Mean percent change from baseline in diurnal IOP at each post-treatment visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of last dose treatment and at the end of clinical trial.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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
    The end of the study when the last visit of the last subject has completed at the last site of all the countries taking part in the study.
    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 months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    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: 157
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 279
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 440
    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)
    At the end of the study, the study drug will not be available so patients that participated in this trial will need other therapy based from the patient physician recommendation that is offered in the market.
    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 Decision2017-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 02 21:00:47 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA