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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

28 april 2011 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Glaukom

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

Fas

Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenta staterna
- California
  - Visalia, California, Förenta staterna, 93277
    - Rekrytering
    - Eye Surgical and Medical Associates
    - Kontakt:
      
      Michael Boone, MD
      
      Telefonnummer: 559-627-9393
      
      E-post: drboone@visaliaeyecare.com
    - Kontakt:
      
      Amy Smith
      
      Telefonnummer: (559)627-9393
      
      E-post: amys@visaliaeyecare.com
    - Underutredare:
      
      Michael Boone, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Tilldelning: Randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Fyrdubbla

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Nanduri, Padma, M.D., FACS

Utredare

Huvudutredare: Padma Nanduri, MD
Studierektor: Michael Boone, MD

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2011

Primärt slutförande (Förväntat)

1 juli 2011

Avslutad studie (Förväntat)