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

15. mars 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

236

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
Legemiddel: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
Eksperimentell: 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.
Legemiddel: AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
Legemiddel: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
Eksperimentell: 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.
Legemiddel: AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
Legemiddel: 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.
Legemiddel: AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Allergan

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2015

Primær fullføring (Faktiske)

1. januar 2016

Studiet fullført (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først innsendt

1. mai 2015

Først innsendt som oppfylte QC-kriteriene

1. mai 2015

Først lagt ut (Anslag)

6. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 223575-002

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