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

NCT03284853 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PG324-CS303
• Study Type: interventional
• Target: 436
• Locations: 11 countries
• Sites: 68

Brief 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

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (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.

  Day 90

Study Arms (2)

Netarsudil/Latanoprost 0.02%/0.005%

EXPERIMENTAL

PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.

Drug: Netarsudil/Latanoprost 0.02%/0.005%

GANFORT®

ACTIVE COMPARATOR

GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.

Drug: GANFORT®

Interventions

Netarsudil/Latanoprost 0.02%/0.005% DRUG

Topical sterile ophthalmic solution

Netarsudil/Latanoprost 0.02%/0.005%

GANFORT® DRUG

Topical sterile ophthalmic solution

GANFORT®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (68)

State Hospital - University Medical Center Academical Department of Ophthalmology

Graz, Austria

Location

Albertgasse 39/10+11

Vienna, Austria

Location

Hanusch Hospital

Vienna, Austria

Location

UZ Leuven, campus Gasthuisberg, Herestraat 49, 3000 Leuven

Leuven, Belgium

Location

Faculty Hospital Brno Eye Department

Brno, 62500, Czechia

Location

Glaucoma center Oční klinika VFN a 1. LF UK

Prague, 12808, Czechia

Location

Ophthalmology Service Centre Francois Xavier Michelet CHU Pellegrin

Bordeaux, France

Location

Centre ophtalmologique Pole vision val d'ouest

Écully, France

Location

Ophthalmology Service - Batiment R Hospital de la Croix-Rousse

Lyon, France

Location

CHU de Nantes-Hospital Hotel Dieu Ophthalmology Service

Nantes, France

Location

Ophthalmology department Necker University Hospital-Enfants Malades

Paris, France

Location

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

Freiburg im Breisgau, 79106, Germany

Location

Department of Ophthalmology Clinical Johannes Gutenberg-University Mainz

Mainz, Germany

Location

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

Münster, Germany

Location

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

Tübingen, Germany

Location

Augenarztpraxis Dr. Andreas Bayer

Weilheim, Germany

Location

Budapest Retina Associates

Budapest, Hungary

Location

Department of Ophthalmology Semmelweis University

Budapest, Hungary

Location

University of Debrecen, Clinical Center, Ophthalmology Department

Debrecen, Hungary

Location

Clinexpert Gyongyos Kft.

Heves, Hungary

Location

Ganglion Medical Center

Pécs, Hungary

Location

University of Szeged, Department of Ophthalmology

Szeged, Hungary

Location

Markusovszky University Teaching Hospital

Szombathely, Hungary

Location

Ophthalmic Clinic DiNOGMI University Hospital San Martino

Genova, Italy

Location

ASST Fatebenefratelli Sacco P.O.L.Sacco

Milan, Italy

Location

ASST Santi Paolo e Carlo - Ophthalmic Clinic

Milan, Italy

Location

Dept. Ophthalmology, San Raffaele Hospital

Milan, Italy

Location

Department of Medicine and Surgery University of Parma

Parma, Italy

Location

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

Pavia, Italy

Location

AOU Pisana Hospital of Cisanello

Pisa, Italy

Location

G.B.Bietti Foundation - IRCCS

Rome, Italy

Location

Senese University Hospital

Siena, Italy

Location

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

Torino, 10146, Italy

Location

University Eye Clinic Ospedale Maggiore

Trieste, Italy

Location

Politecnico Gianbattista Rossi AOUI Ospedale Borgo Roma

Verona, Italy

Location

Signes Ozolinas Doctor Practice in Ophthalmology

Jelgava, Latvia

Location

Latvian American Eye Centre (LAAC)

Riga, Latvia

Location

P.Stradins Clinical University Hospital, Ophthalmology Clinic

Riga, Latvia

Location

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

Riga, Latvia

Location

Professor K. Gibinski University Clinical Centre

Katowice, Poland

Location

Ophthalmic Clinic Jasne Blonia

Lodz, Poland

Location

Department of Diagnostics and Microsurgery of Glaucoma

Lublin, Poland

Location

Military Institute of Medicine Klinika Okulistyki

Warsaw, Poland

Location

Centro de Ojos de la Coruña

A Coruña, Spain

Location

Centro de Oftalmologia Barraquer

Barcelona, Spain

Location

Hospital General de Catalunya Ophthalmology Department

Barcelona, Spain

Location

Hospital QuironSalud Barcelona

Barcelona, Spain

Location

Institut Catala de retina (ICR) Glaucoma and Investigation Department

Barcelona, Spain

Location

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

Cadiz, 11407, Spain

Location

Hospital Universitario Reina Sofía de Córdoba

Córdoba, Spain

Location

Hospital Universitario Virgen Macarena Ophthalmology Department

Seville, Spain

Location

Hospital Universitario de Torrevieja Ophthalmology Department

Torrevieja, Spain

Location

FISABIO-Oftalmología Médica

Valencia, Spain

Location

Ophthalmology Department Hospital Universitario Rio Hortega

Valladolid, Spain

Location

Hospital Clinico Universitario Lozano Blesa Zaragoza Ophthalmology department

Zaragoza, Spain

Location

Hospital Universitario Miguel Servet Ophthalmology Department

Zaragoza, Spain

Location

City Hospitals Sunderland NHS Foundation Trust Sunderland Eye Infirmary

Sunderland, Tyne and Wear, United Kingdom

Location

NHS Grampian Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

Cambridge University Hospitals NHS Trust

Cambridge, United Kingdom

Location

Ophthalmology Department, Queen Alexandra Hospital

Cosham, United Kingdom

Location

Mid-Cheshire Hospitals NHS Foundation Trust

Crewe, United Kingdom

Location

Northwest Anglia NHS Foundation trust Hinchingbrooke Hospital

Huntingdon, United Kingdom

Location

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

London, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Moorfields Eye Hospital NHS

London, United Kingdom

Location

Western Eye Hospital

London, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

Queen Mary Hospital, King's College Hospital NHS

Sidcup, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

netarsudil; Latanoprost; Ganfort

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Michelle Senchyna, PhD. Vice President, Clinical Development & Medical Affairs.
• Organization: Aerie Pharmaceuticals Inc.

msenchyna@aeriepharma.com

+1 908 947 3551

Study Officials

• Michelle Senchyna

  Aerie Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 15, 2017
• Study Start: September 5, 2017
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: January 31, 2022
• Results First Posted: January 19, 2022

Record last verified: 2022-01

Locations

FR (5); ES (13); AU (3); BE (1); LA (4); CZ (2); DE (5); PL (4); IT (12); GB (12); HU (7)