None listed
Conditions
Brief summary
(O-acyl)-hydroxy fatty acids (OAHFA) and Wax esters (WE) are part of the natural lipid layer of the tear film, which helps to stabilize tears, and is believed to maintain comfort. During contact lens wear, the tear film rapidly breaks up, and this may be a reason for people complaining of discomfort during lens wear. The aim of this study is to investigate changes in the ocular surface (corneal and conjunctival staining, non-invasive tear break-up time, and tear lipid layer thickness) of experience contact lens wearers wearing OAHFAs-loaded contact lens, Wax esters (WE) loaded contact lens and commercially available contact lens. The findings from this study will explore the use of OAHFAs and WE to improve the comfort of daily disposable contact lenses. We hypothesize that wearing contact lenses containing OAHFAs or WEs will result in a more stable tear film and increase wearer comfort.
Interventions
The aim of the research is to investigate changes in the surface of your eyes whilst you are wearing daily disposable soft contact lenses embedded with (O-acyl)-hydroxy fatty acids (OAHFA) and Wax Esters(WE) and compare the effect with marketed commercially available contact lenses.
Single center, double masked, randomised study. Three contact lens materials (Comfilcon A, Somofilcon A , and Nesofilcon A) are included in the study, these materials compositions are different, two are silicone hydr
The aim of the research is to investigate changes in the surface of your eyes whilst you are wearing daily disposable soft contact lenses embedded with (O-acyl)-hydroxy fatty acids (OAHFA) and Wax Esters(WE) and compare the effect with marketed commercially available contact lenses. Single center, double masked, randomised study. Three contact lens materials (Comfilcon A, Somofilcon A , and Nesofilcon A) are included in the study, these materials compositions are different, two are silicone hydrogels (comfilcon A, and somofilcon A) and one hydrogel (nesofilcon A). These three contact lens materials loaded with two types of lipids (OAHFA and WE). The loaded six contact lenses types and three commercially available lenses (i.e total nine different types of lenses) are randomised and will be assessed the ocular surface changes in nine study days. ,At the baseline visit, experience contact lens wearers who meet the inclusion criteria will be enrolled in the study by trained optometrist ( he will be the responsible for administering the intervention). after baseline, participant will be asked to attend the clinic on nine different study days with two visits per day (morning and evening).Participants will also be advised not to wear their habitual contact lenses for 24 hours (they can use spectacles instead) prior to each visit, to ensure that there is no potential impact on the eyes from their regular contact lens use. Participants will be asked to schedule their study visits with a minimum 48 hours between morning visits or maximum of seven days between visits (i.e., wash out period). At each visit, the participant will have the health of their eyes confirmed and then wear one of the randomly allocated study lenses for at least 8 hours in both eyes, and after 8 hours of lens wear, we will be assessed the clinical procedures at all visits. We will be maintaining the participant attendance sheet for all visits, and monitoring regularly during the study duration period. This study will be conducted at Eye Research Group clinic suites, School of optometry and vision science, University of New South Wales, Sydney.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
•Aged 18-65 years old (inclusive) •Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. •Experience contact lens wearers. •Refractive correction of -0.50DS to -10.00DS or +0.50 to +1.75DS (inclusive), with <1.00DC (cylinder power) (to ensure contact lens powers available to provide adequate vision correction). •Willing to wear the study contact lenses for approx. 8 hours per day [at all nine visits]. Have health and ocular health findings which would not prevent you from safely wearing contact lenses. •Willing to not use any rewetting eye drops for the during study lens wearing days. •Willing to refrain from swimming, showering and/or sleeping while wearing the study contact lenses for the duration of the study. •Willing to undergo the tests as outlined in the information statement.
Exclusion criteria
•Any active corneal infection or allergies •Any inflammation of the surface of the eye •Pregnancy (or planning pregnancy), lactating/breast feeding, suffering from the systemic diseases Sjögren’s syndrome, rheumatoid arthritis, systemic lupus erythematosus, diabetes and thyroid eye disease or taking the medications atropine, antazoline, azatadine or antihistamines such as cetirizine, brompheniramine. •People who have undergone surgery on the front part of the eye •People with epilepsy
Outcome results
None listed