None listed
Conditions
Brief summary
The hypothesis for this study is that regular lens cleaning (using a rub and rinse technique) with a multipurpose disinfection solution during extended wear exposes the eye to a clean lens surface thereby reducing bacterial build-up on the lens surface resulting in less bacterially driven ocular adverse events.
Interventions
Prospective, open label, bilateral, clinical trial to investigate daily, morning cleaning of silicone hydrogel contact lenses worn during three months extended wear as a strategy for reducing adverse events associated with contact lens wear in neophyte and experienced lens wearers. Lenses will be worn for one month extended wear (i.e. during the day and night). Each morning, following waking, the lenses will be removed, several drops of COMPLETE multipurpose solution easy-rub formula (PHMB/poly
Prospective, open label, bilateral, clinical trial to investigate daily, morning cleaning of silicone hydrogel contact lenses worn during three months extended wear as a strategy for reducing adverse events associated with contact lens wear in neophyte and experienced lens wearers. Lenses will be worn for one month extended wear (i.e. during the day and night). Each morning, following waking, the lenses will be removed, several drops of COMPLETE multipurpose solution easy-rub formula (PHMB/polyhexamethylene biguanide 0.0001%; Abbott Medical Optics, USA) applied to the lens. The lenses are then cleaned by rubbing and then rinsing with the same solution and then reinserting on eye.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Able to read, comprehend English and give informed consent as demonstrated by signing a record of informed consent; -Be at least 18 years old; -Be 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; -Have vision that is 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
-Have previously experienced a severe or significant contact lens related ocular adverse event including microbial keratitis (MK), infiltrative keratitis (IK), contact lens acute red eye (CLARE) and/or contact lens peripherial ulcer (CLPU). -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, Sjogrens 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; -Any rigid gas permeable (RGP) or orthokeratology lens wear within the previous 2 weeks; -Contraindications to contact lens wear; -Currently enrolled in a clinical trial -Participated in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks; -Be pregnant
Outcome results
None listed