The effect of daily cleaning of contact lenses on adverse event rates in new and experienced lens wearers
- Conditions
- The study purpose is to investigate the efficacy of daily morning cleaning of lenses with a multipurpose disinfection solution as a means of reducing contact lens related ocular adverse events.Eye - Normal eye development and function
- Registration Number
- ACTRN12612001098820
- Lead Sponsor
- Brien Holden Vision Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
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.
-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/spectacles.
-Be experienced or inexperienced at wearing contact lenses.
-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 any therapeutic ocular medication up to 4 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.
-Eye surgery within 12 weeks immediately prior to enrolment for this trial.
-Previous corneal refractive surgery.
-Contraindications to contact lens wear.
-Known allergy or intolerance to ingredients in any of the clinical trial products.
-Currently enrolled in another clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if daily cleaning of contact lenses during continuous wear of silicone hydrogel contact lenses reduces the incidence of contact lens related ocular adverse events, including infiltrative keratitis, contact lens induced peripheral ulcer and acute red eye. Assessment will be conducted using a slit lamp biomicroscope.[Baseline, 1 week, 1 month, 3 months]
- Secondary Outcome Measures
Name Time Method To determine if daily cleaning of contact lenses during continuous wear of silicone hydrogel contact lenses reduces the contamination rate of contact lenses. Worn lenses will be removed aseptically by the clinician at monthly scheduled visits, placed in phosphate buffered saline and sent for microbiological analysis.[Baseline, 1 month, 3 months]