None listed
Conditions
Brief summary
Contact lens discomfort or dryness is the primary reason to discontinue using soft contact lenses. Contact lens users with decreased tear volume are more intolerant to lenses (but not tested with daily disposable lenses). Contact lens materials, replacement schedules and care regimens may affect corneal structure and tear physiology . There is an increase in ocular discomfort at end of the day (but there is a paucity of information for daily disposable lens wearers). We have found that Dailies Total 1 has greater comfort than Acuvue TruEye (unpublished data). Also, transferring people to Dailies Total 1 was associated subjects being reclassified as asymptomatic. However, the reason for this change has not been identified. Meibomian glands are oil-producing glands in the eyelids. Their dysfunction is a primary cause of dry eye. Changes in the quality and composition of their oily secretions (meibum) cause tear film instability which might lead to discomfort and dryness during lens wear. Sphingolipids are components of the meibum that play an important role in inflammation. In tears, sphingolipid composition is correlated with tear production and dry eye symptoms in non-contact lens wearers..There are no studies on this relationship during contact lens wear. Somatosensory dysfunction (such as stress and anxiety) may cause dry eyes in the absence of any clinical changes to the ocular structure or tear film.. We have anecdotally noted a relationship between cornea thickness and comfort. This study will determine whether this anecdotal observation can be reproduced by scientific evaluation. The primary outcome is change in physicochemical changes in the tear film To correlate changes in tear film and meibomian gland structure and composition to comfort during contact lens wear. Secondary Outcomes To investigate the relationship between discomfort during lens wear with sleep disturbance.
Interventions
The aim of this study is to investigate changes in the ocular surface of experienced and neophyte (new) contact lens wearers wearing three different types of daily disposable contact lenses.
We will ask participants to use three types of daily disposable contact lenses which are made of different polymers called Somofilcon A, Verofilcon A, and Narafilcon A. Types of lenses will be randomly allocated.
Participants will be asked to wear the contact lenses in both eyes on a daily disposable basis
The aim of this study is to investigate changes in the ocular surface of experienced and neophyte (new) contact lens wearers wearing three different types of daily disposable contact lenses. We will ask participants to use three types of daily disposable contact lenses which are made of different polymers called Somofilcon A, Verofilcon A, and Narafilcon A. Types of lenses will be randomly allocated. Participants will be asked to wear the contact lenses in both eyes on a daily disposable basis for 30(±3) days, for a minimum of 6 hours per day at least 5 days per week and instructed not to sleep in their lenses. Participants will be asked to not wear any contact lenses 18-24 hours before wearing the next set of lenses and 24 hours between each type (washout period). This process will be repeated for all three lens types investigated in this study and each period will be separated by 18-24h. At the next three follow-up visits, different brands of daily disposable contact lenses will be provided to the participants. Lens prescription and clinical assessments will be performed by an optometrist. Participants will be provided one opaque manila envelope at V2 to V4 to bring the foil covers of the worn lenses’ packages in the next visit (this is to ensure that all the lenses were worn by the participants).
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Between 18-40 years old Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Habitual contact lens wear and neophytes Refractive correction of -0.50 to -15.50, -0.25 to -1.75 and +0.50 to +1.75 diopters for myopia, astigmatism, and hyperopia Willing to wear the study contact lenses a minimum of 6 hours per day at least 5 days per week for the duration of the study 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 for the duration of the study. Willing to refrain from swimming, showering and/or sleeping while wearing the contact lenses for the duration of the study
Exclusion criteria
Exclusion criteria • Any active corneal infection, allergies Acute or sub-acute inflammation of the anterior chamber, Pregnancy (or planning pregnancy), lactating/breast feeding, and any systemic disease or medication use that may affect the eye such as diabetes and use of antihistamines, People who have undergone refractive surgery People with neurological disorders such as epilepsy
Outcome results
None listed