The effect of daily cleaning of contact lenses on adverse event rates in new and experienced lens wearers
- Conditions
- The purpose of this study is to investigate the efficacy of regular morning cleaning of lenses with a multipurpose disinfection solution as a means of reducing microbial keratitis and other contact lens related ocular inflammatory adverse events.Eye - Normal eye development and function
- Registration Number
- ACTRN12610000336088
- Lead Sponsor
- Brien Holden Vision Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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;
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method