RecruitingACTRN12612000120875

Evaluation of ocular response and subjective comfort ratings in forty participants with DAILIES TOTAL1 RegisteredTradeMark daily disposable contact lens wear for three months

Prospective, open-label, single group study where a minimum of 40 myopic participants will wear DAILIES TOTAL1 RegisteredTradeMark contact lenses bilaterally on a daily disposable basis for a total of three months to evaluate ocular response and subjective comfort ratings.


Sponsor

Brien Holden Vision Institute

Enrollment

40 participants

Start Date

Mar 7, 2012

Study Type

Interventional

Conditions

Summary

DAILIES TOTAL1 RegisteredTradeMark by CIBA VISION is one of the new silicone hydrogel daily disposable lenses recently released into the contact lens market. This study intends to provide more information on the clinical performance of DAILIES TOTAL1 RegisteredTradeMark in terms of ocular health, vision and subjective comfort. It will allow for comparisons to previous and future contact lens related studies in the hope that it can contribute to further understanding on what causes cotnact lens related discomfort and dryness. The hypothesis of this study is that the ocular responses and subjective comfort ratings will be dissimilar in participants wearing DAILIES TOTAL1 RegisteredTradeMark and other lens types.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how a new type of daily disposable contact lens called DAILIES TOTAL1 affects your eye health and how comfortable it feels over three months. Researchers want to learn more about what makes contact lenses comfortable or uncomfortable, which could help improve lenses in the future. You will be asked to wear these daily disposable lenses and come in for a few check-up visits where a researcher will look at your eyes and ask how they feel. You may be eligible if: - You are 18 years of age or older - You are nearsighted (myopic) and your vision can be corrected to at least 6/12 in each eye with lenses - Your eyes are in generally good health with no conditions that would prevent safe contact lens wear - You are able to put in and take out contact lenses (training can be provided) - You are willing to follow the wearing schedule and attend all study visits - You can read and understand English You may NOT be eligible if: - You have any current eye infection, injury, or condition of the cornea, eyelids, or conjunctiva - You have a systemic disease that affects eye health (e.g., diabetes, Graves disease, lupus, multiple sclerosis) - You use prescription eye drops or medications that affect the eyes - You have had eye surgery in the last 12 weeks - You have had previous corneal refractive surgery (e.g., LASIK) - You are currently pregnant - You are enrolled in another clinical trial Talk to your doctor about whether this trial might be right for you.

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

DAILIES TOTAL1 RegisteredTradeMark contact lenses will be worn on a daily wear, single use basis for a minimum of 5 days per week, at least 6 hours per day (no overnight wear) for a duration of 3 mont

DAILIES TOTAL1 RegisteredTradeMark contact lenses will be worn on a daily wear, single use basis for a minimum of 5 days per week, at least 6 hours per day (no overnight wear) for a duration of 3 months. DAILIES TOTAL1 RegisteredTradeMark contact lenses are made of Delefilcon A material.


Locations(1)

Australia

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ACTRN12612000120875


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