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Open Angle GlaucomaPhase 3NCT03284853

Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension

A Phase 3 study testing Netarsudil/Latanoprost 0.02%/0.005% and GANFORT® in people with Open Angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 68 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Open Angle Glaucoma, Ocular Hypertension
What is being tested?
Netarsudil/Latanoprost 0.02%/0.005% and GANFORT®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
436 participants
Where
68 sitesin 11 countries
Study dates
5 Sep 2017to 6 Nov 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be 18 years of age or older.
  • Diagnosis of OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is acceptable).
  • Subjects insufficiently controlled and/or subjects considered in need for combination therapy by the investigators.
  • Medicated intraocular pressure ≥ 17 mmHg in at least one eye and < 28mmHg in both eyes at screening visit.
  • 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.
  • 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).
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  • Be able and willing to give signed informed consent and follow study instruction.
  • Women must be either of non-childbearing potential, or women with childbearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
  • Women of childbearing 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.
  • Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use an effective form of contraception from time of randomization and for 3 months following the last dose of study medication.
  • 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.

Who cannot join

  • Ophthalmic:
  • 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.
  • Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles i.e. Grade 2 Shaffer (Chan 1981) or less extreme narrow angle with complete or partial closure. Note: Previous laser peripheral iridotomy is NOT acceptable.
  • 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.
  • Treatment-naïve subjects.
  • 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.
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  • Known hypersensitivity to any component of the investigational formulations to be used (e.g., benzalkonium chloride) or to fluorescein.
  • Previous glaucoma intraocular surgery, including SLT or ALT in either eye.
  • Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal cross-linking, keratoplasty).
  • Ocular trauma within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening.
  • 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.
  • 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.
  • Mean central corneal thickness greater than 620μm at screening.
  • Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g., keratoconus).
  • Systemic:
  • Clinically significant abnormalities in laboratory tests at screening.
  • 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).
  • Clinically significant systemic disease which might interfere with the study.
  • Participation in any investigational study within 30 days prior to screening.
  • 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 regime during the study.
  • 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).
  • 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.
  • 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.

Trial locations and contacts

68 sites in 11 countries.

68 sites in 11 countries

Spain13 sites

  • Centro de Ojos de la Coruña

    A Coruña

  • Centro de Oftalmologia Barraquer

    Barcelona

  • Hospital General de Catalunya Ophthalmology Department

    Barcelona

  • Hospital QuironSalud Barcelona

    Barcelona

  • Institut Catala de retina (ICR) Glaucoma and Investigation Department

    Barcelona

  • Hospital General del S.A.S. de Jerez de la Frontera

    Cadiz, 11407

  • Hospital Universitario Reina Sofía de Córdoba

    Córdoba

  • Hospital Universitario Virgen Macarena Ophthalmology Department

    Seville

  • Hospital Universitario de Torrevieja Ophthalmology Department

    Torrevieja

  • FISABIO-Oftalmología Médica

    Valencia

  • Ophthalmology Department Hospital Universitario Rio Hortega

    Valladolid

  • Hospital Clinico Universitario Lozano Blesa Zaragoza Ophthalmology department

    Zaragoza

  • Hospital Universitario Miguel Servet Ophthalmology Department

    Zaragoza

Other trials in Spain

Italy12 sites

  • Ophthalmic Clinic DiNOGMI University Hospital San Martino

    Genova

  • ASST Fatebenefratelli Sacco P.O.L.Sacco

    Milan

  • ASST Santi Paolo e Carlo - Ophthalmic Clinic

    Milan

  • Dept. Ophthalmology, San Raffaele Hospital

    Milan

  • Department of Medicine and Surgery University of Parma

    Parma

  • Ophthamic Clinic of the University of Pavia, IRCCS Foundation San Matteo Policlinic

    Pavia

  • AOU Pisana Hospital of Cisanello

    Pisa

  • G.B.Bietti Foundation - IRCCS

    Rome

  • Senese University Hospital

    Siena

  • S.C.U Oculistica, Azienda Ospedaliero Universitaria, Città della Salute e della Scienza

    Torino, 10146

  • University Eye Clinic Ospedale Maggiore

    Trieste

  • Politecnico Gianbattista Rossi AOUI Ospedale Borgo Roma

    Verona

Other trials in Italy

United Kingdom12 sites

  • NHS Grampian Aberdeen Royal Infirmary

    Aberdeen

  • Cambridge University Hospitals NHS Trust

    Cambridge

  • Ophthalmology Department, Queen Alexandra Hospital

    Cosham

  • Mid-Cheshire Hospitals NHS Foundation Trust

    Crewe

  • Northwest Anglia NHS Foundation trust Hinchingbrooke Hospital

    Huntingdon

  • Guy's & St Thomas' NHS Foundation Trust Glaucoma Research Area

    London

  • King's College Hospital

    London

  • Moorfields Eye Hospital NHS

    London

  • Western Eye Hospital

    London

  • Royal Hallamshire Hospital

    Sheffield

  • Queen Mary Hospital, King's College Hospital NHS

    Sidcup

  • City Hospitals Sunderland NHS Foundation Trust Sunderland Eye Infirmary

    Sunderland, Tyne and Wear

Other trials in United Kingdom

Hungary7 sites

  • Budapest Retina Associates

    Budapest

  • Department of Ophthalmology Semmelweis University

    Budapest

  • University of Debrecen, Clinical Center, Ophthalmology Department

    Debrecen

  • Clinexpert Gyongyos Kft.

    Heves

  • Ganglion Medical Center

    Pécs

  • University of Szeged, Department of Ophthalmology

    Szeged

  • Markusovszky University Teaching Hospital

    Szombathely

Other trials in Hungary

France5 sites

  • Ophthalmology Service Centre Francois Xavier Michelet CHU Pellegrin

    Bordeaux

  • Centre ophtalmologique Pole vision val d'ouest

    Écully

  • Ophthalmology Service - Batiment R Hospital de la Croix-Rousse

    Lyon

  • CHU de Nantes-Hospital Hotel Dieu Ophthalmology Service

    Nantes

  • Ophthalmology department Necker University Hospital-Enfants Malades

    Paris

Other trials in France

Germany5 sites

  • University Medical Center Freiburg, Eye Center,Killianstr.5, Freiburg i. Breisgau

    Freiburg im Breisgau, 79106

  • Department of Ophthalmology Clinical Johannes Gutenberg-University Mainz

    Mainz

  • Universitats-Augenklinik, Studienzentrum/Clinical Trials in Opthalmology (CTO)

    Münster

  • University Eye Hospital Tuebingen, STC eyetrial at the center for Ophthalmolgy

    Tübingen

  • Augenarztpraxis Dr. Andreas Bayer

    Weilheim

Other trials in Germany

Latvia4 sites

  • Signes Ozolinas Doctor Practice in Ophthalmology

    Jelgava

  • Latvian American Eye Centre (LAAC)

    Riga

  • P.Stradins Clinical University Hospital, Ophthalmology Clinic

    Riga

  • Riga East University hospital, In-patient Department "Biķernieki", Ophthalmology Clinic

    Riga

Other trials in Latvia

Poland4 sites

  • Professor K. Gibinski University Clinical Centre

    Katowice

  • Ophthalmic Clinic Jasne Blonia

    Lodz

  • Department of Diagnostics and Microsurgery of Glaucoma

    Lublin

  • Military Institute of Medicine Klinika Okulistyki

    Warsaw

Other trials in Poland

Austria3 sites

  • State Hospital - University Medical Center Academical Department of Ophthalmology

    Graz

  • Albertgasse 39/10+11

    Vienna

  • Hanusch Hospital

    Vienna

Other trials in Austria

Czechia2 sites

  • Faculty Hospital Brno Eye Department

    Brno, 62500

  • Glaucoma center Oční klinika VFN a 1. LF UK

    Prague, 12808

Other trials in Czechia

Belgium1 site

  • UZ Leuven, campus Gasthuisberg, Herestraat 49, 3000 Leuven

    Leuven

Other trials in Belgium

About this study

Official title: 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)

The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure

Being tested
Netarsudil/Latanoprost 0.02%/0.005%, GANFORT®
Medical subject headings
Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Netarsudil/Latanoprost 0.02%/0.005%Drug

    Topical sterile ophthalmic solution

  • GANFORT®Drug

    Topical sterile ophthalmic solution

Study groups in NCT03284853
Study groupRoleWhat they receive
Netarsudil/Latanoprost 0.02%/0.005%ExperimentalPG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.
Receives: Drug: Netarsudil/Latanoprost 0.02%/0.005%
GANFORT®Active comparatorGANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.
Receives: Drug: GANFORT®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry

    Comparison of PG324 to Ganfort for mean intraocular pressure at specified timepoints at Week 2, Week 6 and Month 3.

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2017
  2. Study start5 Sep 2017
  3. Primary completion6 Nov 2020
  4. Study completion6 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
436 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03284853
Sponsor's protocol ID
PG324-CS303
Status last verified
Jan 2022
First submitted
29 Aug 2017
Last updated
31 Jan 2022
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Netarsudil/Latanoprost 0.02%/0.005% and GANFORT® in people with Open Angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 68 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Spain, Italy, United Kingdom, Hungary, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03284853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.

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