Contact Lens Solution ToxicityNCT03193255
Efficacy and Safety of cleadewGP for Rigid Contact Lenses
A study testing OPHTECS cleadew GP in people with Contact Lens Solution Toxicity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Solution Toxicity
- What is being tested?
- OPHTECS cleadew GP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Jun 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Optometry, The Hong Kong Polytechnic University
Kowloon
About this study
Official title: Efficacy and Safety of Povidone Iodine-based Disinfecting Solution (cleadewGP) for Rigid Contact Lenses
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.
Read the 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.
- Conditions
- Contact Lens Solution Toxicity
- Being tested
- OPHTECS cleadew GP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPHTECS cleadew GPDevice
Povidone-iodine based disinfecting solutions for rigid contact lenses
| Study group | Role | What they receive |
|---|---|---|
| No daily lens rubbing | Active comparator | Daily lens disinfection with OPHTECS cleadew GP without lens rubbing Receives: Device: OPHTECS cleadew GP |
| Daily rubbing | Active comparator | Daily lens disinfection with OPHTECS cleadew GP after lens rubbing with cleadew GP Receives: 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 Receives: 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 Receives: Device: OPHTECS cleadew GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (3)
Change in levels of ocular microbiome before and 6 months after ortho-k lens wear
Sample from the lower conjunctiva will be gently taken with cotton swab pre-wet with normal saline before and ortho-k lens wear
Measured: 6 months
Levels of contamination of lens cases
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
Measured: 6 months
Levels of contamination of lenses
Samples will be collected from the left lens surface to test for the presence of microorganisms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start14 Jun 2017
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Contact Lens Solution ToxicityStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Ophtecs Corporation
- Responsible party
- Principal investigator, Pauline Cho, The Hong Kong Polytechnic University
- Investigators
- Pauline Cho, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193255
- Sponsor's protocol ID
- HSEARS20170430002
- Status last verified
- Feb 2021
- First submitted
- 14 Jun 2017
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25788652Guang-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.
PubMed 26993290Trinavarat 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.
PubMed 21916618Isenberg SJ. The ocular application of povidone-iodine. Community Eye Health. 2003;16(46):30-1. No abstract available.
PubMed 17491857Rampat 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.
PubMed 24654799Martin-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.
PubMed 20109451
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Povidone Iodine-based Disinfecting Solution (cleadewGP) for Rigid Contact Lenses
- ClinicalTrials.gov ID
- NCT03193255
- Acronym / sponsor ID
- HSEARS20170430002
- Conditions
- Contact Lens Solution Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Ophtecs Corporation
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No daily lens rubbing | Active comparator | Device: OPHTECS cleadew GPDaily lens disinfection with OPHTECS cleadew GP without lens rubbing |
| Daily rubbing | Active comparator | Device: OPHTECS cleadew GPDaily lens disinfection with OPHTECS cleadew GP after lens rubbing with cleadew GP |
| Daily rubbing with separate cleaner | Active comparator | Device: OPHTECS cleadew GPDaily lens disinfection with OPHTECS cleadew GP after lens rubbing with a daily lipid cleaner |
| Daily rubbing and weekly protein removal | Active comparator | Device: OPHTECS cleadew GPDaily lens disinfection with OPHTECS cleadew GP after daily lipid cleaner followed by weekly protein removal treatment |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPHTECS cleadew GPPovidone-iodine based disinfecting solutions for rigid contact lenses | Device | Daily rubbing, Daily rubbing and weekly protein removal, Daily rubbing with separate cleaner, No daily lens rubbing |
Primary outcome
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
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
3 secondary outcomes
Change in levels of ocular microbiome before and 6 months after ortho-k lens wear
Time frame: 6 months
Levels of contamination of lens cases
Time frame: 6 months
Levels of contamination of lenses
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 25788652Shi 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.
- Background: PubMed 26993290Guang-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.
- Background: PubMed 21916618Trinavarat 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.
- Background: PubMed 17491857Isenberg SJ. The ocular application of povidone-iodine. Community Eye Health. 2003;16(46):30-1. No abstract available.
- Background: PubMed 24654799Rampat 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.
- Background: PubMed 20109451Martin-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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline Cho, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPHTECS cleadew GP in people with Contact Lens Solution Toxicity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective symptoms before and 6 months after lens wear (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193255, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.