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Badanie FID 123320 pod kątem zmniejszenia zaczerwienienia oczu u dzieci i dorosłych

16 października 2026 zaktualizowane przez: Alcon Research

Wieloośrodkowe, randomizowane, podwójnie zamaskowane, kontrolowane pojazdem, w grupach równoległych badanie skuteczności i bezpieczeństwa roztworu okulistycznego FID 123320 do zmniejszania zaczerwienienia oczu u dzieci i dorosłych

The purpose of this study is to assess the safety and efficacy of FID 123320 Ophthalmic Solution (Apraclonidine HCl 0.125%) compared to Vehicle for relieving redness of the eye due to minor eye irritations in pediatric and adult populations.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

This study will enroll 2 cohorts: An adult cohort (Subjects 18 years and older of age from any race and ethnicity) and a pediatric cohort (Subjects 5 - 17 years of age from any race and ethnicity).

The study will consist of 6 scheduled visits for each cohort: Screening and/or Baseline visit (Day -7 to -1, Visit 1), Eligibility verification/Randomization/1st Treatment visit on Day 1 (Visit 2), 2-week follow-up visit on Day 14 (Visit 3), 4-week follow-up visit on Day 28 (Visit 4), 8-week follow-up/Treatment discontinuation visit on Day 56 (Visit 5), and 7-day follow-up after treatment discontinuation/Exit visit on Day 63 (Visit 6). The primary endpoint will be collected at Day 1 (Visit 2).

The expected study duration for each subject is approximately 10 weeks with approximately 8 weeks (56 days) of investigational product (IP) exposure.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

284

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Newport Beach, California, Stany Zjednoczone, 92663
        • Eye Research Foundation
    • Colorado
      • Colorado Springs, Colorado, Stany Zjednoczone, 80907
        • Vision Institute
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40206
        • Butchertown Clinical Trials
    • Massachusetts
      • Andover, Massachusetts, Stany Zjednoczone, 01810
        • Andover Eye Associates
    • North Carolina
      • Apex, North Carolina, Stany Zjednoczone, 27502
        • NC Eye Associates, OD, PLLC
      • Shelby, North Carolina, Stany Zjednoczone, 28150
        • CORE, Inc.
    • Tennessee
      • Memphis, Tennessee, Stany Zjednoczone, 38119
        • Total Eye Care PA
      • Smyrna, Tennessee, Stany Zjednoczone, 37167
        • Advancing Vision Research, LLC

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

5 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Key Inclusion Criteria - Adult Cohort:

  • Capable of giving signed informed consent;
  • Willing and able to follow all instructions and attend all study visits;
  • Able to self-administer eye drops in the opinion of the investigator;
  • Have a history of vasoconstrictor (redness relief drop) use within the last 6 months, have an interest in using over-the-counter (OTC) vasoconstrictor eye drops for redness relief, or would benefit from the use of redness relief drops in the opinion of the investigator;
  • Ocular health within normal limits, including distance best corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart;
  • Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study;
  • Other protocol-defined inclusion criteria may apply.

Key Inclusion Criteria - Pediatric Cohort:

  • All pediatric subjects: Parent or legal guardian signs informed consent;
  • Pediatric subject ages 7-17: Sign an assent form;
  • Subject and parent/legal guardian/care giver: Willing and able to follow all instructions and attend all study visits;
  • Able to self-administer eye drops satisfactorily or have a subject's care provider or parent/legal guardian at home routinely available for this purpose;
  • Ocular health within normal limits; best-corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart;
  • Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study;
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria - Pediatric and Adult Cohorts

  • Known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol;
  • Ocular surgical intervention within 6 months prior to Visit 1 (Day -7 to Day -1) or during the study;
  • History of lid surgery;
  • Ocular condition that, in the opinion of the investigator, could affect the subject's safety or study parameters;
  • Other protocol-specified exclusion criteria may apply.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Apraclonidine HCl 0.125% - Adult Cohort

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).
Lek: Apraclonidine Hydrochloride Ophthalmic Solution

Investigational ophthalmic solution applied topically to the eye with a dropper bottle

Inne nazwy:
  • Apraclonidine HCl 0.125%
Komparator placebo: Vehicle - Adult Cohort

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).
Lek: Vehicle

Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle
Eksperymentalny: Apraclonidine HCl 0.125% - Pediatric Cohort

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).
Lek: Apraclonidine Hydrochloride Ophthalmic Solution

Investigational ophthalmic solution applied topically to the eye with a dropper bottle

Inne nazwy:
  • Apraclonidine HCl 0.125%
Komparator placebo: Vehicle - Pediatric Cohort

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).
Lek: Vehicle

Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 15 Minutes Post-Instillation on Day 1 - Adult Cohort
Ramy czasowe: Baseline (Day 1 pre-instillation); Minute 15 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Minute 15 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 10 Hours (600 Minutes) Post-Instillation on Day 1 - Adult Cohort
Ramy czasowe: Baseline (Day 1 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Hour (60 Minutes) Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Ramy czasowe: Baseline (Day 1 pre-instillation); Hour 1 (60 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Hour 1 (60 minutes) (Day 1 post-instillation)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Adult Cohort
Ramy czasowe: Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Minute 1 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 8 Hours (480 Minutes) Post-instillation on Day 1 - Adult Cohort
Ramy czasowe: Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 12 Hours (720 Minutes) Post-Instillation on Day 1 - Adult Cohort
Ramy czasowe: Baseline (Day 1 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-instillation on Day 1 (Visit 2) - Adult Cohort
Ramy czasowe: Baseline (Day 1 pre-instillation); Second 30 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Second 30 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Ramy czasowe: Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Minute 1 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 8 Hours (480 Minutes) Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Ramy czasowe: Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Ramy czasowe: Baseline (Day 1 pre-instillation); Second 30 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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 change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Second 30 (Day 1 post-instillation)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Alcon Research

Śledczy

  • Dyrektor Studium: Sr. Clinical Trial Lead, Pharma, Alcon Research, LLC

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

7 października 2024

Zakończenie podstawowe (Rzeczywisty)

27 stycznia 2025

Ukończenie studiów (Rzeczywisty)

3 kwietnia 2025

Daty rejestracji na studia

Pierwszy przesłany

2 sierpnia 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 sierpnia 2024

Pierwszy wysłany (Rzeczywisty)

6 sierpnia 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • DEW422-C003

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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