None listed
Conditions
Brief summary
To determine whether contact lenses coated with melimine can be worn safely and prevent bacterial colonization of their surface. the control marketed contact lenses have no coating. Both type of lenses have same material Etafilcon A. Both the dispensing optometrists and contact lens wearers will be masked.
Interventions
Comparison of the performance of antimicrobial melimine coated contact lenses to standard marketed contact lenses with 2 week extended wear basis. Subjects will wear a test melimine coated antimicrobial lens in one eye, and the control uncoated marketed lens in the other eye (extended wear means uninterrupted day and night wear). The contact lens material is same, Etafilcon A. The total duration for innervation is 3 months and will include total 7 study visits that will confirm the adherence to
Comparison of the performance of antimicrobial melimine coated contact lenses to standard marketed contact lenses with 2 week extended wear basis. Subjects will wear a test melimine coated antimicrobial lens in one eye, and the control uncoated marketed lens in the other eye (extended wear means uninterrupted day and night wear). The contact lens material is same, Etafilcon A. The total duration for innervation is 3 months and will include total 7 study visits that will confirm the adherence to intervention protocols. After the study finishes, subjects will be followed up after 1 month (with own spectacles/contact lenses) to rule out any delayed effects.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
*Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. *Be at least 18 years old, male or female. *Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator. *Have vision that is correctable to at least 6/12 (20/40) or better in each eye with contact lenses/spectacles. *Require contact lens correction in each eye between -0.75 and -6.00 D inclusive.
Exclusion criteria
*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’s disease, and auto-immune 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; *Use of or a need for any therapeutic ocular medication at enrolment (that would be required to be discontinued during the study); *Use of or a need for any 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 manner or risk providing a false positive. *Eye surgery within 12 weeks immediately prior to enrolment for this trial. *Previous corneal refractive surgery. *Known allergy or intolerance to ingredients in any of the study products. *Currently enrolled in another clinical trial or participation in a clinical trial within the previous 2 weeks. *Pregnancy or lactating (Testing of pregnancy is not required. A participant’s verbal report is sufficient).
Outcome results
None listed