Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Completed · Not applicable
Conditions studied: Astigmatism
In brief
The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.
Key facts
- Study ID
- NCT04831515
- Run by
- CooperVision, Inc.
- People needed
- 48
- Starts
- 2021-03-29
- Expected to finish
- 2021-07-02
- Last updated by the study team
- 2022-02-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Is at least 18 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self reports having a full eye examination in the previous two years;
- Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
- Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
- Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
- Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters
You may not qualify if…
- Is participating in any concurrent clinical or research study;
- Habitually wears one of the study contact lenses;
- Has any known active ocular disease and/or infection that contraindicates contact lens wear;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery or intraocular surgery.
Where it is running
- Golden Optometric Group — Whittier, California, United States
- Golden Vision — Sarasota, Florida, United States
- Sacco Eye Group — Vestal, New York, United States
- Athens Eye Care — Athens, Ohio, United States
Full record on ClinicalTrials.gov
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