Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease

15. marts 2019 opdateret af: Allergan
This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

236

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85003
        • Arizona Center for Clinical Trials
    • California
      • Glendale, California, Forenede Stater, 91203
        • Specialty Eye Ctr. Med. Group
      • Newport Beach, California, Forenede Stater, 92663
        • The Eye Research Foundation
      • Santa Ana, California, Forenede Stater, 92705
        • WCCT Global
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Eye Associates of Colorado Springs
    • Florida
      • Lecanto, Florida, Forenede Stater, 34491
        • West Coast Eye Institute
    • Georgia
      • Morrow, Georgia, Forenede Stater, 30260
        • Eye Care Centers Management, Inc.
      • Roswell, Georgia, Forenede Stater, 30076
        • Coastal Research Assoc. LLC
    • Illinois
      • Hoffman Estates, Illinois, Forenede Stater, 60169
        • Chicago Cornea Consultants
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66211
        • Durrie Vision
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Kentucky Center for Vision
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Medical Center/ Tufts University School of Medicine
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64154
        • Moyes Eye Center
      • Saint Louis, Missouri, Forenede Stater, 63131
        • Ophthalmology Associates
      • Washington, Missouri, Forenede Stater, 63090
        • Comprehensive Eye Care Ltd.
    • New York
      • New York, New York, Forenede Stater, 10013
        • Raymond Fong MD, PC
      • Wantagh, New York, Forenede Stater, 11793
        • South Shore Eye Care LLP
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28210
        • SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose
      • High Point, North Carolina, Forenede Stater, 27262
        • Cornerstone Eye Care
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45236
        • Eye Care Associates of Greater Cincinnati
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Mark A. Terry, MD PC/ Devers Eye Institute
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29414
        • Bluestein Custom Vision
      • Florence, South Carolina, Forenede Stater, 29501
        • Carolinas Centers for Sight, PC
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Black Hills Regional Eye Institute
    • Texas
      • Austin, Texas, Forenede Stater, 78731
        • Keystone Clinical Research
      • Houston, Texas, Forenede Stater, 77055
        • Whitsett Vision Group
      • Houston, Texas, Forenede Stater, 77025
        • Houston Eye Associates
      • San Antonio, Texas, Forenede Stater, 78240
        • Medical Center Opth. Assoc.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Signs and symptoms of dry eye disease
  • Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.

Exclusion Criteria:

  • History of glaucoma, or ocular hypertension
  • Diagnosis of ocular infection
  • Use of contact lenses in the past 14 days or expected use during the study
  • Use of any topical ophthalmic medications in the past 30 days
  • Use of corticosteroids in the past 30 days.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AGN-223575 Dose A
1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
Medicin: AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
Medicin: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
Eksperimentel: AGN-223575 Dose B
1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
Medicin: AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
Medicin: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
Eksperimentel: AGN-223575 Dose C
1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
Medicin: AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
Medicin: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
Placebo komparator: AGN-223575 Vehicle
1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
Medicin: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
Tidsramme: Baseline, Day 14
Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement.
Baseline, Day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale
Tidsramme: Baseline, Day 14
OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning in patients with dry eye disease. The participants rate each question on a 5-point scale where: 0=none of the time to 4=all of the time. The scores are totaled over the 12 questions and normalized/converted to a total score of 0=no disability to 100=complete disability. Higher OSDI scores are associated with greater severity. A negative change from Baseline indicates improvement.
Baseline, Day 14
Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale
Tidsramme: Baseline, Day 14
The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale where: 0=no staining to 5=diffuse staining. The higher the grade score, the worse the dry eye severity. A negative change from Baseline indicates improvement.
Baseline, Day 14
Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye
Tidsramme: Day 14
A participant was considered a redness responder if the study quadrant redness score based on the Allergan Dry Eye Redness Scale in the study eye was 0=Normal (no redness).
Day 14

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Allergan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2015

Primær færdiggørelse (Faktiske)

1. januar 2016

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

1. maj 2015

Først indsendt, der opfyldte QC-kriterier

1. maj 2015

Først opslået (Skøn)

6. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 223575-002

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Syndromer med tørre øjne

Kliniske forsøg med AGN-223575 ophthalmic solution

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Congo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner