Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
Completed · Not applicable
Conditions studied: Astigmatism
In brief
The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.
Key facts
- Study ID
- NCT05933772
- Run by
- CooperVision International Limited (CVIL)
- People needed
- 50
- Starts
- 2023-08-18
- Expected to finish
- 2023-12-28
- Last updated by the study team
- 2025-03-11
Who can join
Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Is between 18 and 39 years of age (inclusive) 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, 6 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears of toric soft contact lenses binocularly.
- No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;
- the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:
- i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage)
- ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))
- iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%))
- iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage)
- v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage)
- vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage)
- vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage)
- Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;
- Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;
- Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters
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
- Kannarr Eye Care — Pittsburg, Kansas, United States
- Sacco Eye Group — Vestal, New York, United States
- ProCare Vision Center — Granville, Ohio, United States
- Eyes on Sheppard Clinic — Toronto, Ontario, Canada
- Spadina Optometry — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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