CompletedPhase 4ACTRN12609000430235

A prospective, single-masked, cross-over, randomised clinical trial assessing ocular comfort and ocular changes with and without lens replacement during the day with AIR OPTIX (trademark) AQUA contact lenses worn by experienced wearers over three days


Sponsor

CIBA VISION

Enrollment

20 participants

Start Date

Aug 7, 2009

Study Type

Interventional

Conditions

Summary

The aim of this trial is to assess changes in ocular comfort during the day, and whether ocular comfort is influenced by new lens replacement or re-insertion with the same lens after a brief soak in saline, during the day. The trial also aims to assess ocular changes and whether these correlate with changes in comfort. The hypothesis for this trial is ocular comfort will decrease with lens wear during the day whether lenses are replaced, the same lens is re-inserted or the same lens is worn uninterrupted for the day.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study assesses how comfortable AIR OPTIX AQUA contact lenses are when worn with and without lens replacement during the day. Experienced contact lens wearers aged 18 to 75 will test the lenses over three days to measure comfort and eye health changes.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a prospective, single-masked, cross-over, randomised clinical trial, with participants wearing AIR OPTIX AQUA contact lenses bilaterally over 3 days following initial lens dispense. Particip

This is a prospective, single-masked, cross-over, randomised clinical trial, with participants wearing AIR OPTIX AQUA contact lenses bilaterally over 3 days following initial lens dispense. Participants will initially be fitted with contact lenses . This is followed by three days of wear with the same lens type. Each day corresponds to one stage of the study. For two of the stages, participants will insert their own study lenses and these will be removed after approximately five hours of wear. Either the same lenses will be re-inserted after a brief soak in saline or a new pair of lenses will be inserted. For the other stage, participants will insert their own study lenses and wear the same lenses for the day without removal. The order in which this occurs will be randomised for all stages and masked when lenses are removed during the day. Subjective responses will also be evaluated at regular intervals during each stage. It is expected that most participants will have six scheduled visits, comprising the baseline visit followed by two stages with two visits per stage and one stage with one visit. * Baseline visit * Stages where lenses removed during the day o Visit 1 o Visit 2 * Stage where lenses not removed during the day: o Visit 1 * Take home questionnaires (THQ) at regular intervals during the day for all stages


Locations(1)

Australia

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ACTRN12609000430235


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