Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design
Completed · Not applicable
Conditions studied: Presbyopia
In brief
The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.
Key facts
- Study ID
- NCT04952701
- Run by
- CooperVision, Inc.
- People needed
- 63
- Starts
- 2021-10-21
- Expected to finish
- 2022-01-14
- Last updated by the study team
- 2022-04-27
Who can join
Age: 42 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Is at least 42 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 8 hours a day, 5 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
- Has refractive astigmatism no higher than -0.75DC;
- Is presbyopic and requires a reading addition of at least +0.75D and no more than
- +2.50D;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)
You may not qualify if…
- Is participating in any concurrent clinical or research study;
- 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
- Coan EyeCare — Ocoee, Florida, United States
- Kannarr Eye care — Pittsburg, Kansas, United States
- Sacco Eye Group PLLC — Vestal, New York, United States
- ProCare Vision Center — Granville, Ohio, United States
- Nittany Eye Associates — College, Pennsylvania, United States
Full record on ClinicalTrials.gov
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