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

Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

28. april 2011 opdateret af: Nanduri, Padma, M.D., FACS

Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy

The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied to the outside of one eyelid.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.

Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

22

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
    • California
      • Visalia, California, Forenede Stater, 93277
        • Rekruttering
        • Eye Surgical and Medical Associates
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Michael Boone, MD

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
  • Male or Female patients aged at least 18 years of age.
  • Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
  • A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential
  • Best-Corrected Visual Acuity of 20/800 or better in both eyes
  • Written informed consent.
  • Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.

Exclusion Criteria:

  • Uncontrolled glaucoma
  • Glaucoma requiring more than a single agent for IOP control
  • Patients with a corneal thickness greater then 620 micrometers
  • Female patients who are pregnant, nursing, or planning a pregnancy during the study
  • Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
  • Uncontrolled or labile hypertension
  • At the conclusion of the washout period any study participant with an IOP lower than 22 or greater than 35 mmHg.

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Intraocular Pressure
Tidsramme: Day one, every hour for twelve hours.
Day one, every hour for twelve hours.
Heart Rate
Tidsramme: Day one, every hour for twelve hours.
Day one, every hour for twelve hours.
Blood Pressure
Tidsramme: Day one, every hour for twelve hours.
Day one, every hour for twelve hours.
Intraocular Pressure
Tidsramme: Day two twice, once in the AM, once in the PM.
Day two twice, once in the AM, once in the PM.
Intraocular Pressure
Tidsramme: Day seven, once.
Day seven, once.
Intraocular Pressure
Tidsramme: Day fourteen, once.
Day fourteen, once.
Intraocular Pressure
Tidsramme: Day twenty one, once.
Day twenty one, once.
Intraocular Pressure
Tidsramme: Day twenty eight, once.
Day twenty eight, once.
Heart Rate
Tidsramme: Day two twice, once in the AM, once in the PM.
Day two twice, once in the AM, once in the PM.
Heart Rate
Tidsramme: Day seven, once.
Day seven, once.
Heart Rate
Tidsramme: Day fourteen, once.
Day fourteen, once.
Heart Rate
Tidsramme: Day twenty one, once.
Day twenty one, once.
Heart Rate
Tidsramme: Day twenty eight, once.
Day twenty eight, once.
Blood Pressure
Tidsramme: Day two twice, once in the AM, once in the PM.
Day two twice, once in the AM, once in the PM.
Blood Pressure
Tidsramme: Day seven, once.
Day seven, once.
Blood Pressure
Tidsramme: Day fourteen, once.
Day fourteen, once.
Blood Pressure
Tidsramme: Day twenty one, once.
Day twenty one, once.
Blood Pressure
Tidsramme: Day twenty eight, once.
Day twenty eight, once.

Samarbejdspartnere og efterforskere

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

Sponsor

Nanduri, Padma, M.D., FACS

Efterforskere

  • Ledende efterforsker: Padma Nanduri, MD
  • Studieleder: Michael Boone, MD

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. april 2011

Primær færdiggørelse (Forventet)

1. juli 2011

Studieafslutning (Forventet)

1. juli 2011

Datoer for studieregistrering

Først indsendt

27. april 2011

Først indsendt, der opfyldte QC-kriterier

28. april 2011

Først opslået (Skøn)

2. maj 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. maj 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2011

Sidst verificeret

1. april 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • White Rabbit 2010-0001

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 Brimonidine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Russia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner