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An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults

26. August 2026 aktualisiert von: Alcon Research

A Multicenter, Randomized, Vehicle-Controlled Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness in Adult Subjects

The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness caused by minor eye irritations.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks. Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office. Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation. Eye redness will be assessed before and after instillation at prespecified timepoints.

Studientyp

Interventionell

Einschreibung (Geschätzt)

178

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Texas
      • Fort Worth, Texas, Vereinigte Staaten, 76134
        • Contact Alcon Call Center for Trial Locations

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Key Inclusion Criteria:

  • Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form.
  • Willing and able to follow all instructions and attend all study visits.
  • History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.
  • Baseline ocular redness score of 0.5 unit or higher in at least one eye at Visit 1 and greater than 1 unit on a 5-point scale in both eyes prior to randomization at Visit 2.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Known contraindications or sensitivity to the use of any of the study treatment(s) or their components, or any other medication required by the protocol.
  • Ocular surgical interventions within 6 months prior to Visit 1 or during the study.
  • Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study parameters.
  • Use of prohibited medications, devices, or treatments as specified in the protocol.
  • Out of range vital signs (blood pressure and/or pulse rate) as defined in the study protocol.
  • Abnormal intraocular pressure.
  • Other protocol-defined exclusion criteria may apply.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Vehicle
One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.
Arzneimittel: Vehicle
Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free formulation
Experimental: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.
Arzneimittel: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free formulation
Andere Namen:
  • FID 123472
  • Apraclonidin 0,125 % UDPF

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
Zeitfenster: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)
Change from baseline in investigator-assessed ocular redness at 600 minutes post-instillation on Day 1
Zeitfenster: Baseline (Day 1 pretreatment); 600 minutes post-instillation (Day 1)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pretreatment); 600 minutes post-instillation (Day 1)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
Zeitfenster: Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).
Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)
Change from baseline in investigator-assessed ocular redness at 720 minutes post-instillation on Day 1
Zeitfenster: Baseline (Day 1 pretreatment); 720 minutes post-instillation (Day 1)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).
Baseline (Day 1 pretreatment); 720 minutes post-instillation (Day 1)
Change from baseline in investigator-assessed ocular redness at 30 seconds post-instillation on Day 1
Zeitfenster: Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).
Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
Number of subjects who achieve prespecified improvements from baseline in investigator-assessed ocular redness score in both eyes at 30 seconds post-instillation on Day 1
Zeitfenster: Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The 30-second score will be compared to the baseline score. The number of subjects with improvements as prespecified in the protocol will be reported.
Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Alcon Research

Ermittler

  • Studienleiter: Clinical Trial Lead, Pharma, Alcon Research, LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Mai 2026

Zuerst gepostet (Tatsächlich)

11. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DEW261-C003

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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