- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00538304
A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
10. april 2019 opdateret af: Allergan
A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
222
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater
-
-
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:
- Chronic glaucoma or ocular hypertension
- IOP controlled on Xalatan
Exclusion Criteria:
- Uncontrolled medical conditions
- Known hypersensitivity to study medications
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: 2
placebo
|
1 drop in each eye daily for 1 month
|
Eksperimentel: 1
bimatoprost eye drops
|
1 drop in each eye daily for 1 month
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
|
Baseline, Month 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
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.
|
Baseline, Month 1
|
Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1
Tidsramme: Month 1
|
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.
|
Month 1
|
Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1
Tidsramme: Month 1
|
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
|
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
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. november 2007
Primær færdiggørelse (Faktiske)
1. maj 2008
Studieafslutning (Faktiske)
1. maj 2008
Datoer for studieregistrering
Først indsendt
28. september 2007
Først indsendt, der opfyldte QC-kriterier
1. oktober 2007
Først opslået (Skøn)
2. oktober 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 192024-035
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 .
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