None listed
Conditions
Brief summary
Contact lens discomfort and its associated dryness are the primary reasons to discontinue using contact lenses. In addition, users with decreased tear volume are more prone to be intolerant to soft contact lenses. The lipids (oils) of the tear film are produced in the meibomian glands in the eyelids, and these lipids are delivered from the meibomian glands to the eye to form part of the tear film lipid layer. This layer promotes tear film stability and prevents drying of the ocular surface. Several of these lipids help stabilize and spread tears across the ocular surface and retard tear evaporation. The amount of lipids in tears is reduced in people with dry eyes, and dry eye is related to contact lens discomfort. Contact lens discomfort is worse when people's meibomian glands are blocked. Therefore, we hypothesize that adding lipids back to the eye during contact lens wear will help form a stable tear film and reduce dry eye sensations. We and many others have shown that delivering components from contact lenses is preferable to delivering by eyedrops as more of the component remains on the eye. The aim of this study is to investigate changes in the ocular surface (corneal and conjunctival staining, non-invasive tear break-up time, and comfort level) of experienced contact lens wearers wearing oil-loaded contact lenses. This study was designed as a single-center, double-masked, randomized study. At the baseline visit, experienced contact lens wearers who meet the inclusion criteria will be enrolled in the study. After baseline, participants will be asked to attend the clinic on three different days with two visits per day (morning and evening). The same lens will be worn in both eyes, all participants will wear all three lens types (in total, three visits), and the lenses will be randomly assigned for wear. Participants will randomly wear oil-imbibed lenses (O-L), control lenses that contain only small particles of surfactant with no oil (C-L), and normal commercially available contact lenses (M-L). The primary endpoint is the changes in the tear break-up time of contact lens wearers over the 8 hours of lens wear.
Interventions
It’s a crossover trial, in which three different contact lenses will be evaluated: (i) Comfilcon A contact lenses with (O-acyl)-hydroxy fatty acids and surfactant (ii) Comfilcon A contact lenses with surfactant only, and (iii) the marketed Comfilcon A contact lenses will act as the control. There will be a 24-hour washout period between treatments. The lens power (strength) will range from -0.50 to -7.50D or +0.50 to +1.75D (inclusive), with < 1.00 DC (cylinder power). A record book/attendance s
It’s a crossover trial, in which three different contact lenses will be evaluated: (i) Comfilcon A contact lenses with (O-acyl)-hydroxy fatty acids and surfactant (ii) Comfilcon A contact lenses with surfactant only, and (iii) the marketed Comfilcon A contact lenses will act as the control. There will be a 24-hour washout period between treatments. The lens power (strength) will range from -0.50 to -7.50D or +0.50 to +1.75D (inclusive), with < 1.00 DC (cylinder power). A record book/attendance sheet will be used to monitor adherence or fidelity to the intervention. The same lens type will be worn in both eyes and the order of lens wear will be randomly assigned. All participants will wear each lens type on a single occasion for approximately 8 hours.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
• Aged 18-45 years old (inclusive) • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. • Habitual contact lens wearer • Spherical refractive error between -0.50 to -7.50D or +0.50 to +1.75D (inclusive), with < 1.00 DC (cylinder power) • Able to achieve a minimum 6/9.5 binocular visual acuity while wearing the study lenses (with over-spectacles if required) • Willing to wear the study contact lenses for a minimum of 8 hours per day. • Willing to refrain from wearing their habitual contact lenses for a minimum of 24 hours prior to each visit • Have health and ocular health findings which would not prevent the participant from safely wearing contact lenses • Willing to not use any rewetting eye drops on the morning of study visits and while wearing the study contact lenses • Willing to refrain from swimming, showering, and/or sleeping while wearing the study contact lenses • Willing to undergo the tests as outlined in the information statement.
Exclusion criteria
• Gas permeable contact lens wearer • Any active corneal infection, ocular allergies • Recent or short-term inflammation in the front part 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 refractive surgery • People with epilepsy
Outcome results
None listed