The effect of daily cleaning of contact lenses on adverse event rates in new and experienced lens wearers

INTERVENTION: Prospective, controlled, 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). For the test group, each morning following waking, the lenses will be removed, several drops of Biotrue multipurpose solution applied to the lens. The lenses are then cleaned by rubbing and then rinsing with the same solution and then reinserted on eye. CONDITION: 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. PRIMARY OUTCOME: 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. SECONDARY OUTCOME: 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. 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, 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.