N/A
Completed N=48
Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Astigmatism
Source: ClinicalTrials.gov NCT04831515 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Overall Ease of Lens Handling — 9.0; 8.8 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Ease of Lens Handling |
9.0; 8.8 | — |
| SECONDARY Visual Acuity |
-0.06; -0.05 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04831515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.