- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03193255
Efficacy and Safety of cleadewGP for Rigid Contact Lenses
Efficacy and Safety of Povidone Iodine-based Disinfecting Solution (cleadewGP) for Rigid Contact Lenses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Multipurpose solutions (MPS) are the most commonly prescribed regimen to clean, disinfect and rinse rigid lenses. These solutions usually contain quaternary ammonium compounds (QAC) which have been shown to be selective for carriage of organisms harbouring QAC genes in orthokeratology (ortho-k) lens wear and it raises concerns about safety with the increasing popularity of orthokeratology (ortho-k) for myopia control in children. Hydrogen peroxide system is a good alternative but this option is limited in rigid lens market. The only brand available in Hong Kong labelled as safe for rigid contact lenses has limited disinfecting power. cleadewGP (Ophtecs, Japan) is a new disinfecting solution for rigid contact lenses which does not employ QAC and instead is povidone iodine (PVI) based. PVI has been safely used as a disinfectant for ophthalmic operations and is commonly used in eye drops. PVI-based soft and rigid lens solutions have been reported to be as effective against Pseudomonas aeruginosa as other MPS and hydrogen peroxide-based solutions. However, other efficacy against other organisms need to be demonstrated to allow this solution to meet FDA requirements. The PVI-based soft lens solution was also reported to be effective against Acanthamoeba. cleadewGP is relatively new in the market and not much work has been done on the efficacy and safety of this solution. If confirmed to be effective and safe, cleadewGP may be a better alternative to ortho-k lens wearers who need to use disinfecting solutions at least for a few years while under ortho-k treatment. In the absence of QAC, there will be no concern of selection of carriage of organisms harbouring QAC genes in ortho-k lens wearers using this disinfecting solution over time.
The current study aims at investigating the effectiveness and safety of the cleadewGP for cleaning (lipid and protein removal) and disinfecting of ortho-k lenses by comparing the outcomes collected from subjects randomly assigned to one of the following study groups.
Group 1: cleadewGP without lens rubbing Group 2: cleadewGP with lens rubbing Group 3: cleadewGP with separate daily cleaner Group 4: cleadewGP with separate daily cleaner and weekly protein removal agent
Four study visits will be involved in this 6 months study: baseline, 1-month, 3-month, and 6-month after lens wear. Complimentary solutions will be provided during the study period. Solutions and accessories will be replaced at monthly interval. Effectiveness for cleaning and disinfection and safety of lens wear will be determined by comparing the changes in ocular microbiome before and after lens wear, contamination levels of lenses and accessories, biomicroscopic examination of lenses and eyes, and subjective rating of lens comfort among the four groups of subjects.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kowloon, Hong Kong
- School of Optometry, The Hong Kong Polytechnic University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: No daily lens rubbing
Daily lens disinfection with OPHTECS cleadew GP without lens rubbing
|
Povidone-iodine based disinfecting solutions for rigid contact lenses
|
Active Comparator: Daily rubbing
Daily lens disinfection with OPHTECS cleadew GP after lens rubbing with cleadew GP
|
Povidone-iodine based disinfecting solutions for rigid contact lenses
|
Active Comparator: Daily rubbing with separate cleaner
Daily lens disinfection with OPHTECS cleadew GP after lens rubbing with a daily lipid cleaner
|
Povidone-iodine based disinfecting solutions for rigid contact lenses
|
Active Comparator: Daily rubbing and weekly protein removal
Daily lens disinfection with OPHTECS cleadew GP after daily lipid cleaner followed by weekly protein removal treatment
|
Povidone-iodine based disinfecting solutions for rigid contact lenses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in subjective symptoms before and 6 months after lens wear
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Grading of corneal staining, limbal injection and conjunctival injection under slitlamp biomicroscopy before and after ortho-k lens wear
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in levels of ocular microbiome before and 6 months after ortho-k lens wear
Time Frame: 6 months
|
Sample from the lower conjunctiva will be gently taken with cotton swab pre-wet with normal saline before and ortho-k lens wear
|
6 months
|
Levels of contamination of lens cases
Time Frame: 6 months
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Sample will be collected from the left compartment of the lens case to determine the presence of microorganisms.
The right compartment of the lens case will be tested for the presence and amount of biofilm
|
6 months
|
Levels of contamination of lenses
Time Frame: 6 months
|
Samples will be collected from the left lens surface to test for the presence of microorganisms
|
6 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSEARS20170430002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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