RecruitingACTRN12623000064606

Impact of new contact lens disinfectants on Contact Lens Discomfort

Investigation of the effect of contact lens disinfectants on signs and symptoms of contact lens discomfort in adult daily contact lens wearers

Sponsor

University of New South Wales

Enrollment

20 participants

Start Date

Jun 14, 2023

Study Type

Interventional

Conditions

Contatct lens discomfort

Summary

• The aim of this study is to evaluate the impact of contact lens disinfectants on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. Participants will wear Comfilcon A contact lenses over a 6-week, changing their lenses every two weeks, a commonly recommended wear schedule and use new contact lens disinfectants (Cleadew MPS,Ophtecs Corp., Japan) • The primary endpoint is the changes in the ocular surface and tears of contact lens wearer over the first six weeks of lens wear using new lens care product. • The secondary endpoint is changes in factors that have been reported to be different between comfortable and uncomfortable contact lens wearers.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Contact lens discomfort is one of the most common reasons people stop wearing lenses altogether. The solution used to clean and store contact lenses plays a significant role in how comfortable the lenses feel and how well the eye's surface tolerates them over time. A new multipurpose contact lens disinfectant called Cleadew (by Ophtecs, Japan) is being evaluated in this study to see whether it affects the comfort, tear film, and surface health of the eye differently from existing solutions. Participants will wear a specific brand of contact lens (Comfilcon A) with the Cleadew solution for six weeks, changing lenses every two weeks. Researchers will use a range of tests at the start and end of the study — measuring the tear film, checking the surface of the eye with specialised dye and a microscope, and asking participants about their symptoms — to see how the eye responds to the new solution over time. You may be eligible if you are 18 or older, have been wearing contact lenses for at least 6 months on a daily wear basis (at least 4 days per week, at least 6 hours per day), and have no significant eye surface damage. You must be willing to avoid eye drops and not swim, shower, or sleep in your lenses during the study. Pregnant women, people on any eye or systemic medications, and those with eye disease or prior eye surgery are excluded. The study is run by UNSW.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The aim of this study is to evaluate the impact of contact lens disinfectants on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. We will a

The aim of this study is to evaluate the impact of contact lens disinfectants on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. We will ask participants to wear Comfilcon A contact lenses at least 5 days per week for at least 6 hours per day, wearing the same lenses for 2 weeks and then replaced with new lenses every 2 weeks, as a commonly recommended wear schedule. Participants also will be asked to use new contact lens disinfectants (Cleadew MPS,Ophtecs Corp., Japan) containing polyhexamethylene biguanide hydrochloride and Alexidine dihydrochloride as the main ingredients in the following manner: Every day after lens removal, gently rub and wash both sides of the lens with the disinfectant 20-30 times per side and soak the lens in the disinfectant for at least 4 hours or over nights. In addition, before wearing the lenses, participants will rinse them with the disinfectant for at least 5 seconds before starting to wear them. The eligible subjects will be provided with lenses and disinfectants and will be instructed cleaning/disinfection procedures at the first visit, and participants are then asked to have a clinical examination and sample collection for a total of one hour each time at the clinic three times: at the first visit, 3 weeks later (visit #2), and 6 weeks later (visit #3) with each visit lasting a total of approximately one hour. Clinical examinations include visual acuity test, slit-lamp biomicroscopy with corneal and conjunctival staining, phenol red thread test, contact lens dry eye questionnaire, tear volume, noninvasive tear fluid layer thickness, meibography, and noninvasive tear fluid layer thickness measurement. All the Interventions including examinations and instructions are performed by trained investigator, including optometrists and Japanese ophthalmologists.

Locations(1)

School of Optometry and Vision Science - Kensington

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12623000064606