Assessment of tear stability and comfort when wearing oil-laden daily disposable contact lenses
- Conditions
- Contact lens related discomfortEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12624000762550
- Lead Sponsor
- niversity of New South Wales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
•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.
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on-invasive tear breakup time [Oculus Keratograph 5M Baseline and after 8 hours of lens wear]
- Secondary Outcome Measures
Name Time Method Subjective comfort[Questionnaires on paper record forms (questionnaire validated)<br>The bilateral subjective questionnaire with 0-100 scale Baseline, and after 4 hours and 8 hours of lens wear]