Efficacy and Safety of cleadewGP for Rigid Contact Lenses

February 14, 2021 updated by: Pauline Cho, The Hong Kong Polytechnic University

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • School of Optometry, The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: OPHTECS cleadew GP
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
Device: OPHTECS 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
Device: OPHTECS cleadew GP
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
Device: OPHTECS cleadew GP
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
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

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

OPHTECS Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2017

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 14, 2021

Last Verified

February 1, 2021

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)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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