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An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert (OLE2)

26. marts 2019 opdateret af: ForSight Vision5, Inc.

An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004

This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

81

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
    • Arkansas
      • Fayetteville, Arkansas, Forenede Stater, 72704
        • Vold Vision
    • California
      • Artesia, California, Forenede Stater, 90701
        • Sall Medical Research Center
      • Newport Beach, California, Forenede Stater, 92663
        • Eye Research Foundation
    • Georgia
      • Morrow, Georgia, Forenede Stater, 30260
        • Clayton Eye Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Mundorf Eye Center
      • High Point, North Carolina, Forenede Stater, 27262
        • Cornerstone Health Care; Cornerstone Eye Care
    • Tennessee
      • Maryville, Tennessee, Forenede Stater, 37803
        • University Eye Specialists
      • Memphis, Tennessee, Forenede Stater, 38119
        • Total Eye Care
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • R&R Eye Research, LLC

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:

  1. Completed FSV5-004 study.
  2. Written informed consent prior to any study procedure.
  3. Willingness to comply with the visit schedule.

Key Exclusion Criteria:

  1. Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
  2. Subjects who will require contact lens use during the study period.
  3. Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 13 mg Bimatoprost Ocular Insert
13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
Medicin: Bimatoprost
Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
Andre navne:
  • "Lumigan" er mærkenavnet for bimatoprost i form af øjendråber

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
Tidsramme: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
Baseline (Day 0, enrollment in this study) to end of study (Week 38)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Intraocular Pressure (IOP)
Tidsramme: Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
IOP is a measurement of the fluid pressure inside the eye. IOP measurements were taken at 8 am (Time (T)=0 hour) at Weeks 4, 8, 12, 24 and 38. Diurnal IOP measurements were also taken at 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 12, 24 and 38. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the Randomization visit (Day 0) of study FSV5-004.
Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
Percentage of Participants by Subject-Reported Comfort Assessment Categories
Tidsramme: Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
The participant assessed their overall comfort with ocular inserts using the following rating choices: Not aware of inserts, very comfortable; Aware of inserts, and comfortable; Tolerable, but mild discomfort; Moderate discomfort or Severe discomfort. The percentage of participants in each rating category is reported.
Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
Bimatoprost Ocular Insert Retention Duration
Tidsramme: Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
Insert duration was defined as the total duration (in days) that any ocular insert remained in place for each subject, measured from the date of Insert removal minus date of Insert placement + 1.
Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
Percentage of Participants Who Received Rescue Treatment
Tidsramme: Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.
Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
Change From Baseline in Endothelial Cell Count
Tidsramme: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
Density (number of cells/mm^2) of corneal endothelial cells was determined at four sites using specular microscopy of the central corneal endothelium at Baseline and at Week 38.
Baseline (Day 0, enrollment in this study) to end of study (Week 38)

Samarbejdspartnere og efterforskere

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

Sponsor

ForSight Vision5, Inc.

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 (Faktiske)

10. august 2015

Primær færdiggørelse (Faktiske)

11. august 2016

Studieafslutning (Faktiske)

11. august 2016

Datoer for studieregistrering

Først indsendt

27. august 2015

Først indsendt, der opfyldte QC-kriterier

28. august 2015

Først opslået (Skøn)

1. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FSV5-005 OLE 2

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 Okulær hypertension

Kliniske forsøg med Bimatoprost

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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