NCT03193255|Completed
Efficacy and Safety of cleadewGP for Rigid Contact Lenses
Efficacy and Safety of Povidone Iodine-based Disinfecting Solution (cleadewGP) for Rigid Contact Lenses
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Efficacy and Safety of Povidone Iodine-based Disinfecting Solution (cleadewGP) for Rigid Contact Lenses
Sponsor study identifier
interventional
80
1 country
1
Study Start
June 14, 2017
Actual (reported)Primary Completion
August 1, 2019
Actual (reported)Study Completion
August 1, 2019
Actual (reported)Multipurpose solutions (MPS) are the most commonly prescribed regimen to clean, disinfect and rinse rigid lenses. The preservatives used in MPS may cause hypersensitivity and the presence of quaternary ammonium compounds (QAC) may increase development of antiseptic resistance mediated by QAC resistance genes, thus lowering the efficacy of disinfection. Povidone-iodine (PVI) has been safely used as a disinfectant for ophthalmic operations and eye drops. The cleadew GP (Ophtecs, Japan) tested in the current study is a PVI based rigid lens disinfecting solutions which does not employ QAC. If its efficacy and safety can be confirmed in this study, it will be a good alternative rigid lens care regimen for children.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2017
Actual (reported)June 14, 2017
Actual (reported)June 20, 2017
Actual (reported)August 1, 2019
Actual (reported)August 1, 2019
Actual (reported)Change in subjective symptoms before and 6 months after lens wear
Questionnaire of ocular comfort will be administered to rate symptoms of discomfort, itching, tearing, dryness and redness
6 months
Change in corneal staining and injection before and 6 months after ortho-k lens wear
Grading of corneal staining, limbal injection and conjunctival injection under slitlamp biomicroscopy before and after ortho-k lens wear
6 months
Change in levels of ocular microbiome before and 6 months after ortho-k lens wear
6 months
Levels of contamination of lens cases
6 months
Levels of contamination of lenses
6 months
Daily lens disinfection with OPHTECS cleadew GP without lens rubbing
Daily lens disinfection with OPHTECS cleadew GP after lens rubbing with cleadew GP
Daily lens disinfection with OPHTECS cleadew GP after lens rubbing with a daily lipid cleaner
Povidone-iodine based disinfecting solutions for rigid contact lenses
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
School of Optometry, The Hong Kong Polytechnic University
Kowloon, Hong Kong
Shi GS, Boost M, Cho P. Prevalence of antiseptic-resistance genes in staphylococci isolated from orthokeratology lens and spectacle wearers in Hong Kong. Invest Ophthalmol Vis Sci. 2015 May;56(5):3069-74. doi: 10.1167/iovs.15-16550.
Guang-Sen S, Boost M, Cho P. Prevalence of antiseptic resistance genes increases in staphylococcal isolates from orthokeratology lens wearers over initial six-month period of use. Eur J Clin Microbiol Infect Dis. 2016 Jun;35(6):955-62. doi: 10.1007/s10096-016-2622-z. Epub 2016 Mar 18.
Pauline Cho, PhD
The Hong Kong Polytechnic University
80 participants (actual enrollment reported by the registry).
First Submitted
June 14, 2017
First Posted
June 20, 2017
Study Start
June 14, 2017
Actual (reported)Daily lens disinfection with OPHTECS cleadew GP after daily lipid cleaner followed by weekly protein removal treatment
Contact the study team to confirm eligibility.
Trinavarat A, Atchaneeyasakul LO. Treatment of epidemic keratoconjunctivitis with 2% povidone-iodine: a pilot study. J Ocul Pharmacol Ther. 2012 Feb;28(1):53-8. doi: 10.1089/jop.2011.0082. Epub 2011 Sep 14.
Isenberg SJ. The ocular application of povidone-iodine. Community Eye Health. 2003;16(46):30-1. No abstract available.
Rampat R, Jain S. The effect of commonly used surgical solutions on the tensile strength of sutures. J Pediatr Ophthalmol Strabismus. 2014 May-Jun;51(3):189-90. doi: 10.3928/01913913-20140318-01. Epub 2014 Mar 25.
Martin-Navarro CM, Lorenzo-Morales J, Lopez-Arencibia A, Valladares B, Pinero JE. Acanthamoeba spp.: efficacy of Bioclen FR One Step, a povidone-iodine based system for the disinfection of contact lenses. Exp Parasitol. 2010 Sep;126(1):109-12. doi: 10.1016/j.exppara.2010.01.018. Epub 2010 Jan 28.
Primary Completion
August 1, 2019
Actual (reported)Study Completion
August 1, 2019
Actual (reported)Last Updated
February 16, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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