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NCT03193255

Efficacy and Safety of cleadewGP for Rigid Contact Lenses

Completed NA Last updated 16 February 2021
What this trial tests

NA trial testing OPHTECS cleadew GP in Contact Lens Solution Toxicity in 80 participants. Completed in 1 August 2019.

Timeline
14 June 2017
Primary endpoint
1 August 2019
1 August 2019

Quick facts

Lead sponsorThe Hong Kong Polytechnic University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment80
Start date14 June 2017
Primary completion1 August 2019
Estimated completion1 August 2019
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

The Hong Kong Polytechnic University

Who can join

Adults 6 to 10, any sex, with Contact Lens Solution Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Investigation of effects of orthokeratology and povidone iodine disinfecting solution on the conjunctival microbiome using MALDI-TOF mass spectrometry.
    Boost MV, Cheung SW, Cho P. · · 2021 · PMID 37846320 · DOI 10.1016/j.aopr.2022.100024

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