None listed
Conditions
Brief summary
The primary purpose of the study is to assess microbial contamination of antibacterial contact lens cases when used in conjunction with marketed contact lenses worn on a daily wear and monthly replacement schedule and to compare the results to a historical control. Hypothesis: antibacterial lens cases will have less contamination inside the lens storage case than a regular lens case
Interventions
This is a prospective, bilateral, open-label, randomised clinical trial with participants wearing commercially available PureVision [Trade mark] contact lenses in conjunction with an Synergi contact lens care solution and i-clean [registered] contact lens case, over a 3 month period on a daily wear basis.
All participants will use the same product types. There are visits at 2 weeks, 1 month and 3 months from initial lens fitting. Contact lens cases will be collected at the 1 month and 3 months v
This is a prospective, bilateral, open-label, randomised clinical trial with participants wearing commercially available PureVision [Trade mark] contact lenses in conjunction with an Synergi contact lens care solution and i-clean [registered] contact lens case, over a 3 month period on a daily wear basis. All participants will use the same product types. There are visits at 2 weeks, 1 month and 3 months from initial lens fitting. Contact lens cases will be collected at the 1 month and 3 months visits for analysis. This study will have a of minimum of 40 participants.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
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; -Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; -Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses; -Has vision correctable to at least 6/12 (20/40) or better in each eye with 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 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 concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial; -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. N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial; -Eye surgery within 12 weeks immediately prior to enrolment for this trial; -Previous corneal refractive surgery; -Contraindications to contact lens wear; -Currently enrolled in another clinical trial; -Be pregnant* The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests. * Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
Outcome results
None listed