A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
10. april 2019 oppdatert av: Allergan
A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
222
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Georgia
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Atlanta, Georgia, Forente stater
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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:
- Chronic glaucoma or ocular hypertension
- IOP controlled on Xalatan
Exclusion Criteria:
- Uncontrolled medical conditions
- Known hypersensitivity to study medications
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: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: 2
placebo
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1 drop in each eye daily for 1 month
|
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Eksperimentell: 1
bimatoprost eye drops
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1 drop in each eye daily for 1 month
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
Tidsramme: Baseline, Month 1
|
Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness).
Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).
The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1.
A positive number severity grade change from baseline indicated an increase in redness.
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Baseline, Month 1
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1
Tidsramme: Month 1
|
Percentage of patients with a >= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point.
Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).
|
Month 1
|
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Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1
Tidsramme: Baseline, Month 1
|
Change from baseline in mean (average) IOP at Month 1 8 AM timepoint.
IOP is a measurement of the fluid pressure inside the eye.
For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements.
A negative number change from Baseline indicated a reduction in IOP.
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Baseline, Month 1
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Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1
Tidsramme: Month 1
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Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question.
Physicians were asked "Overall, based on how well this drug lowered THIS patient's IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?".
The responses were extremely willing, very willing, somewhat willing and not willing.
If not willing, physician was asked for reason.
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Month 1
|
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Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1
Tidsramme: Month 1
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Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question.
Patients were asked "Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?".
The responses were extremely willing, very willing, somewhat willing and not willing.
If not willing, patient was asked for reason.
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Month 1
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Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1
Tidsramme: Month 1
|
Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study.
Patients were asked "Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?".
The responses were yes or no.
If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor's office told them to expect.
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Month 1
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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. november 2007
Primær fullføring (Faktiske)
1. mai 2008
Studiet fullført (Faktiske)
1. mai 2008
Datoer for studieregistrering
Først innsendt
28. september 2007
Først innsendt som oppfylte QC-kriteriene
1. oktober 2007
Først lagt ut (Anslag)
2. oktober 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 192024-035
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .