None listed
Conditions
Brief summary
To determine whether contact lenses coated with melimine can be worn safely and prevent bacterial colonization of their surface. Both the dispensing optometrists and contact lens wearers will be masked.
Interventions
Comparison of the performance of antimicrobial melimine contact lenses to standard marketed contact lenses with 1 week extended wear basis. Subjects will wear a test antimicrobial lens in one eye, and the control marketed lens in the other eye (extended wear means uninterrupted day and night wear). Participants will be wearing same set of lenses. The duration for innervation is 1 week and will include total 4 study visits that will confirm the adherence to intervention protocols. After the study
Comparison of the performance of antimicrobial melimine contact lenses to standard marketed contact lenses with 1 week extended wear basis. Subjects will wear a test antimicrobial lens in one eye, and the control marketed lens in the other eye (extended wear means uninterrupted day and night wear). Participants will be wearing same set of lenses. The duration for innervation is 1 week and will include total 4 study visits that will confirm the adherence to intervention protocols. After the study finishes, subjects will be followed up after 1 week and 4 weeks (with own spectacles/contact lenses) to rule out any delayed effects.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
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 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;
Outcome results
None listed