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

26 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

178

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Texas
      • Fort Worth, Texas, États-Unis, 76134
        • Contact Alcon Call Center for Trial Locations

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: 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.
Médicament: Vehicle
Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free formulation
Expérimental: 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.
Médicament: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free formulation
Autres noms:
  • FID 123472
  • Apraclonidine 0,125% UDPF

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Alcon Research

Les enquêteurs

  • Directeur d'études: Clinical Trial Lead, Pharma, Alcon Research, LLC

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

5 mai 2026

Première soumission répondant aux critères de contrôle qualité

5 mai 2026

Première publication (Réel)

11 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DEW261-C003

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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