Evaluation of the clinical performance and retention of antimicrobial activity of melimine coated contact lenses
- Conditions
- Clinical performance of antimicrobial contact lens wear.Eye - Normal eye development and function
- Registration Number
- ACTRN12613000369729
- Lead Sponsor
- Brien Holden Vision Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Subjects enrolled in the trial must:
Be able to read, comprehend and give informed consent as demonstrated by signing a record of informed consent.
Be at least 18 years old.
Be willing and able to comply with the lens wearing and clinical trial visit schedule as directed by the by the Investigator.
Have ocular health findings considered as normal” and which would not prevent the subject from safely wearing contact lenses.
Have vision correctable to at least 6/12 (20/40) or better in each eye with spherical contact lenses.
Be experienced or may be inexperienced at wearing contact lenses.
Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the
cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact
lenses;Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
An active corneal infection or any active ocular disease that would affect wearing of contact lenses;Previously experienced a severe contact lens related adverse event (Investigator discretion), that is likely to affect their contact lens wear experience or present a significant safety risk during the trial;
Any prescribed systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology or contact lens performance either in an adverse or beneficial manner; N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial; Contraindications to contact lens wear;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular health of subjects, evaluated by detailed slit lamp examinations, ocular signs and symptoms.[assessed after 2 hours, 1 day and at the end of the study (1 week)]
- Secondary Outcome Measures
Name Time Method To determine whether melimine coated lenses retain antibacterial efficacy after wear; evaluated by laboratory testing of retention of activity[Lenses will be assessed on after each week of wear.];Well being of the eye health; Additional follow ups will help to rule out any delayed toxicity. Standard vision screening and detail ocular examination will be carried out including slit lamp bio-microscopy.[4 weeks after the last study visit]