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Rocklatan van de volgende generatie

6 november 2026 bijgewerkt door: Alcon Research

Een fase II, prospectieve, tweefasige, dubbel gemaskeerde, gerandomiseerde, multicentrische, gecontroleerde dosis-responsstudie ter beoordeling van de veiligheid en oculaire hypotensieve werkzaamheid van AR-17043 en PG043 (AR-17043/Latanoprost) oftalmologische oplossingen bij proefpersonen Met verhoogde intraoculaire druk

The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The study consists of two sequential stages under a single protocol. Stage 1 and Stage 2 will enroll independent participant cohorts. Subject enrolled in Stage 1 will not be eligible to participate in Stage 2.

During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.

During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

646

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Dothan, Alabama, Verenigde Staten, 36301
        • Trinity Research Group
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85003
        • Eye Doctors of Arizona
    • California
      • Garden Grove, California, Verenigde Staten, 92843
        • Orange County Ophthalmology Medical Group
      • Inglewood, California, Verenigde Staten, 90301
        • United Medical Research Institute
      • Newport Beach, California, Verenigde Staten, 92663
        • Eye Research Foundation
      • Petaluma, California, Verenigde Staten, 94954
        • North Bay Eye Associates
    • Colorado
      • Fort Collins, Colorado, Verenigde Staten, 80528
        • Eye Center of Northern Colorado, PC
    • Florida
      • Delray Beach, Florida, Verenigde Staten, 33484
        • Glaucoma Specialists of South Florida
      • Delray Beach, Florida, Verenigde Staten, 33484
        • Bruce A. Segal MD
      • Lakeland, Florida, Verenigde Staten, 33805
        • Central Florida Eye Associates
      • Mt. Dora, Florida, Verenigde Staten, 32757
        • Mid Florida Eye Center
      • Venice, Florida, Verenigde Staten, 34285
        • Center For Sight
    • Georgia
      • Roswell, Georgia, Verenigde Staten, 30076
        • Coastal Research Associates
    • Missouri
      • Kansas City, Missouri, Verenigde Staten, 64154
        • Moyes Eye Center
    • New York
      • Rochester, New York, Verenigde Staten, 14618
        • Rochester Ophthalmological Group
    • North Carolina
      • Winston-Salem, North Carolina, Verenigde Staten, 27101
        • James D. Branch Ophthalmology
    • North Dakota
      • Fargo, North Dakota, Verenigde Staten, 58103
        • Bergstrom Eye Research
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45242
        • Cincinnati Eye Institute
      • Cincinnati, Ohio, Verenigde Staten, 45236
        • Midwest Eye Center
    • Pennsylvania
      • Cranberry Township, Pennsylvania, Verenigde Staten, 16066
        • Scott & Christie and Associates, PC
    • South Carolina
      • Mt. Pleasant, South Carolina, Verenigde Staten, 29464
        • Carolina Eyecare Physicians LLC
    • Tennessee
      • Maryville, Tennessee, Verenigde Staten, 37803
        • University Eye Specialists
      • Memphis, Tennessee, Verenigde Staten, 38119
        • Total Eye Care PA
    • Texas
      • Dallas, Texas, Verenigde Staten, 75243
        • Key-Whitman Eye Center
    • Virginia
      • Lynchburg, Virginia, Verenigde Staten, 24502
        • Piedmont Eye Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Stage 1 Key Inclusion Criteria;

  • Diagnosis of OAG or OHT in both eyes.
  • High unmedicated IOP measurements in the study eye as specified in the protocol.
  • Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye.
  • Other protocol-specified inclusion criteria may apply.

Stage 2 Key Inclusion Criteria:

  • Diagnosis of OAG or OHT in both eyes.
  • High unmedicated IOP measurements in the study eye as specified in the protocol.
  • Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
  • Other protocol-specified inclusion criteria may apply.

Stage 1 and Stage 2 Key Exclusion Criteria:

  • Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
  • Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
  • Glaucoma other than OAG.
  • Previous glaucoma surgery.
  • Any abnormality preventing reliable measurements.
  • Unable to demonstrate proper eyedrop instillation.
  • Other protocol-specified exclusion criteria may apply.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: AR-17043 low concentration (Stage 1)

AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Geneesmiddel: AR-17043 Ophthalmic Solution

Investigational monotherapy
Experimenteel: AR-17043 medium concentration (Stage 1)

AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Geneesmiddel: AR-17043 Ophthalmic Solution

Investigational monotherapy
Experimenteel: AR-17043 high concentration (Stage 1)

AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Geneesmiddel: AR-17043 Ophthalmic Solution

Investigational monotherapy
Placebo-vergelijker: AR-17043 vehicle (Stage 1)

AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Geneesmiddel: AR-17043 Vehicle

Placebo comparator
Actieve vergelijker: Rhopressa (Stage 1)

Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Geneesmiddel: Netarsudil 0.02% Ophthalmic Solution

Marketed monotherapy

Andere namen:
  • Rhopressa®
Experimenteel: PG043 low concentration (Stage 2)

PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Geneesmiddel: PG043 Ophthalmic Solution

Investigational fixed dose combination
Experimenteel: PG043 high concentration (Stage 2)

PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Geneesmiddel: PG043 Ophthalmic Solution

Investigational fixed dose combination
Actieve vergelijker: AR-17043 high concentration (Stage 2)

AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Geneesmiddel: AR-17043 Ophthalmic Solution

Investigational monotherapy
Actieve vergelijker: Latanoprost (Stage 2)

Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Geneesmiddel: Latanoprost 0.005% Ophthalmic Solution

Marketed monotherapy

Andere namen:
  • Latanoprost
Actieve vergelijker: Rocklatan (Stage 2)

Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Geneesmiddel: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution

Marketed fixed dose combination

Andere namen:
  • Rocklatan®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean diurnal IOP at Day 8 (Stage 1)
Tijdsspanne: Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements.
Day 8 (8:00, 10:00, 12:00, 16:00)
Mean diurnal IOP at Day 29 (Stage 2)
Tijdsspanne: Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements.
Day 29 (8:00, 10:00, 16:00)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean IOP at each post-treatment timepoint (Stage 1)
Tijdsspanne: Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.
Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Tijdsspanne: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Tijdsspanne: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Tijdsspanne: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Tijdsspanne: Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean IOP at each post-treatment timepoint (Stage 2)
Tijdsspanne: Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.
Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
Tijdsspanne: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
Tijdsspanne: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
Tijdsspanne: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
Tijdsspanne: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alcon Research

Onderzoekers

  • Studie directeur: Clinical Trial Lead, Pharma, Alcon Research, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 september 2024

Primaire voltooiing (Werkelijk)

14 november 2025

Studie voltooiing (Werkelijk)

14 november 2025

Studieregistratiedata

Eerst ingediend

29 mei 2024

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2024

Eerst geplaatst (Werkelijk)

4 juni 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GLR305-E001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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