Efficacy and Safety of cleadewGP for Rigid Contact Lenses

NCT03193255 | Completed

• 1 other identifier: HSEARS20170430002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contact Lens Solution Toxicity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

Study Arms (4)

No daily lens rubbing

ACTIVE COMPARATOR

Daily lens disinfection with OPHTECS cleadew GP without lens rubbing

Device: OPHTECS cleadew GP

Daily rubbing

ACTIVE COMPARATOR

Daily lens disinfection with OPHTECS cleadew GP after lens rubbing with cleadew GP

Device: OPHTECS cleadew GP

Daily rubbing with separate cleaner

ACTIVE COMPARATOR

Daily lens disinfection with OPHTECS cleadew GP after lens rubbing with a daily lipid cleaner

Device: OPHTECS cleadew GP

Daily rubbing and weekly protein removal

ACTIVE COMPARATOR

Daily lens disinfection with OPHTECS cleadew GP after daily lipid cleaner followed by weekly protein removal treatment

Device: OPHTECS cleadew GP

Interventions

OPHTECS cleadew GP DEVICE

Povidone-iodine based disinfecting solutions for rigid contact lenses

Daily rubbing; Daily rubbing and weekly protein removal; Daily rubbing with separate cleaner; No daily lens rubbing

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• cycloplegic objective sphere between -1.00D to -4.00D
• cycloplegic objective astigmatism ≤ 2.00D
• anisometropia \< 1.00D
• best-corrected logMAR visual acuity 0.10 or better in both eyes
• symmetrical corneal topography with toricity ≤ 2.00D
• normal ocular health

You may not qualify if:

• contraindication to ortho-k wear
• prior history of myopia control treatment
• prior history of rigid contact lens wear
• strabismus or amblyopia
• systemic or ocular conditions which might affect refractive development
• poor response or poor compliance to lens wear including poor lens handling, poor vision, and/ocular response after lens modifications

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Ophtecs Corporation: collaborator

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

Related Publications (6)

• 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.

  PMID: 25788652 BACKGROUND

• 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.

  PMID: 26993290 BACKGROUND

• 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.

  PMID: 21916618 BACKGROUND

• Isenberg SJ. The ocular application of povidone-iodine. Community Eye Health. 2003;16(46):30-1. No abstract available.

  PMID: 17491857 BACKGROUND

• 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.

  PMID: 24654799 BACKGROUND

• 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.

  PMID: 20109451 BACKGROUND

Study Officials

• Pauline Cho, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 20, 2017
• Study Start: June 14, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

HK (1)