The effect of new contact lens disinfectant solution on the contact lens discomfort

Not Applicable

• Conditions: Eye - Diseases / disorders of the eye; Contatct lens discomfort

• Registration Number: ACTRN12623001252606
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-04
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Be at least 18 years of age,
•Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
•Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. Contact lenses should have been worn on daily wear modality, where the lenses are worn for at least 6hours per day and remove the lenses before sleep.
•Willing to wear their lenses a minimum of 6 hours per day at least 5 days per week for the duration of the study (12 weeks),
•Willing to not use any rewetting eye drops for the duration of the study and to refrain from swimming, showering and/or sleeping while wearing the contact lenses for the duration of the study.
•Willing to undergo the tests outlined in the section 3 of this form.
•Experience symptoms of contact lens discomfort (CLD), defined as CLDEQ-8 Questionnaire score more than 13.
•Have health and ocular health, defined as no fluorescein after a single instillation of non-preserved fluorescein solution followed by examination 1 minute after instillation, considering minimal staining of grade 1 as normal in contact lens wearers.
•Normal corrected vision, defined as a minimum of 20/40 best corrected visual acuity in each eye.

Exclusion Criteria

•Any active corneal infection, allergies, and Acute or sub-acute inflammation of the anterior chamber.
•Severe insufficiency of lacrimal secretion (dry eye, less than or equal to 10mm for Phenol red thread test at Baseline).
•Any systemic disease or medication use that may affect the eye such as diabetes and use of antihistamines,
•People who have undergone corneal refractive surgery and neurological disorder such as epilepsy.
•Be pregnant, planning to become pregnant during the 6 weeks of the study or be lactating (any participant that does become pregnant during the study should inform the study personnel immediately so that they can be withdrawn from the study since the increased level of hormones can impact ocular comfort during lens wear).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the changes in dynamics of tear fluid on the ocular surface.<br>These are assessed by slit-lamp biomicroscope and meibography by analysing the blinking behaviour.<br>ocular physiology, expressed as a composite of changes in the ocular surface including meibomian glands and tears.<br>Ocular surface will be evaluated by slit-lamp biomicroscope and meibography.[ Base line, 28, 56 and 84 days after using contact lenses and a new lens care product.<br>Primary timepoint will be 84 days];Ocular surface will be evaluated by slit-lamp biomicroscope[ Base line, 28, 56 and 84 days after using contact lenses and a new lens care product.<br>Primary timepoint will be 84 days]

Secondary Outcome Measures

Name	Time	Method
Contact lens dry eye questionnaires-8 (CLDEQ) will be used to evaluate the discomfortable during contact lens wear[ Base line, 28, 56 and 84 days after using contact lenses and a new lens care product.<br>secondary timepoint will be 84 days]