A combination povidone-iodine 0.4%/dexamethasone 0.1% ophthalmic suspension in the treatment of adenoviral conjunctivitis
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  • 作者:J. S. Pelletier (1)
    K. Stewart (1)
    W. Trattler (2)
    D. C. Ritterband (3) (6)
    S. Braverman (4)
    C. M. Samson (3) (5) (6)
    B. Liang (5)
    J. A. Capriotti (1) (5)
  • 关键词:adenovirus ; conjunctivitis ; cornea ; ocular infection ; pink eye ; povidone ; iodine ; PVP ; I ; steroids
  • 刊名:Advances in Therapy
  • 出版年:2009
  • 出版时间:August 2009
  • 年:2009
  • 卷:26
  • 期:8
  • 页码:776-783
  • 全文大小:189KB
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    5. Clinicaltrials.gov web site. An evaluation of the efficacy and safety of AL-46383A ophthalmic solution for the treatment of adenoviral conjunctivitis. Identifier: NCT00901693. Available at: http://clinicaltrials.gov/ct2/results?term=NCT00901693. Accessed August 2009.
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  • 作者单位:J. S. Pelletier (1)
    K. Stewart (1)
    W. Trattler (2)
    D. C. Ritterband (3) (6)
    S. Braverman (4)
    C. M. Samson (3) (5) (6)
    B. Liang (5)
    J. A. Capriotti (1) (5)

    1. Ocean Ophthalmology Group, North Miami Beach, Florida, USA
    2. The Center for Excellence in Eye Care, Miami, Florida, USA
    3. New York Eye and Ear Infirmary, New York, New York, USA
    6. New York Medical College, Valhalla, New York, USA
    4. Braverman Eye Center, Hallandale Beach, Florida, USA
    5. CLS Pharmaceuticals, New York, New York, USA
文摘
Introduction The objective of this pilot study was to determine the preliminary efficacy of a novel ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% in the treatment of adenoviral conjunctivitis. Methods A prospective, open-label, single-armed, phase II clinical trial in humans. Eligible patients with the clinical signs and symptoms of acute conjunctivitis who tested positive for adenoviral antigen by Rapid Pathogen Screening (RPS) Adeno Detector?were enrolled in a single treatment arm consisting of a combination povidone-iodine 0.4%/dexamethasone 0.1% sterile ophthalmic suspension given four times daily for a minimum of 5 days. RPS Adeno Detector testing was performed at baseline and at each follow-up visit along with ocular fluid sampling by conjunctival swabs. Subsequent analysis performed on all swabs included both adenoviral titer by quantitative polymerase chain reaction (qPCR) and cell culture with confirmatory immunofluorescence (CC-IFA). The primary endpoint was clinical resolution of conjunctival injection and discharge. Secondary measures included reduction of qPCR titers and eradication of infectious virus as determined by CC-IFA. Results A total of nine eyes of six patients with clinical signs and symptoms of acute viral conjunctivitis and a positive RPS Adeno Detector test result were enrolled in the study. In eight/nine eyes enrolled in the study, clinical resolution was observed by day 3 or day 4. In six/six eyes with detectable adenovirus by qPCR, significant reduction in viral titer was seen by day 3, day 4, or day 5. In five/six eyes with infectious virus confirmed by CC-IFA at enrollment, elimination of infectivity was achieved by day 4 or day 5. One patient was lost to follow-up. Conclusions An ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% may be a useful agent in the treatment of acute RPS Adeno Detector-positive conjunctivitis. A further placebo-controlled study with a larger number of patients is warranted.

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