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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

28. april 2011 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Grønn stær

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

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
- California
  - Visalia, California, Forente stater, 93277
    - Rekruttering
    - Eye Surgical and Medical Associates
    - Ta kontakt med:
      
      Michael Boone, MD
      
      Telefonnummer: 559-627-9393
      
      E-post: drboone@visaliaeyecare.com
    - Ta kontakt med:
      
      Amy Smith
      
      Telefonnummer: (559)627-9393
      
      E-post: amys@visaliaeyecare.com
    - Underetterforsker:
      
      Michael Boone, MD

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

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

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

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

Hva måler studien?

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.

Samarbeidspartnere og etterforskere

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

Sponsor

Nanduri, Padma, M.D., FACS

Etterforskere

Hovedetterforsker: Padma Nanduri, MD
Studieleder: Michael Boone, MD

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. april 2011

Primær fullføring (Forventet)

1. juli 2011

Studiet fullført (Forventet)