N/A
N=23
A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT02555098 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Subjective Ratings for Comfort — 89; 80 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sapphire contact lenses (Device); senofilcon A contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Ratings for Comfort |
85; 72 | — |
| PRIMARY Subjective Ratings for Comfort |
85; 72 | — |
| PRIMARY Subjective Ratings for Comfort Preference |
68; 27; 5 | — |
| PRIMARY Subjective Ratings for Comfort Preference |
68; 27; 5 | — |
| PRIMARY Subjective Assessment of Visual Quality |
81; 73 | — |
| PRIMARY Subjective Assessment of Visual Quality |
81; 73 | — |
| PRIMARY Subjective Assessment of Overall Satisfaction |
87; 73 | — |
| PRIMARY Subjective Assessment of Overall Satisfaction |
87; 73 | — |
| PRIMARY Subjective Overall Preference |
73; 4; 23 | — |
| PRIMARY Subjective Overall Preference |
73; 4; 23 | — |
Summary
This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.
The study results were not used for design validation of the investigational product.
Eligibility Criteria
Inclusion Criteria
- A person is eligible for inclusion in the study if they:
- Are at least 18 years of age and have full legal capacity to volunteer;
- Have read and signed an information consent letter;
- Are willing and able to follow instructions and maintain the appointment schedule;
- Are an adapted soft contact lens wearer;
- Require spectacle lens powers in both eyes;
- Sphere: between -1.75 to -6.00 diopters and
- Astigmatism: between -1.00 to -2.25 and
- Axis: 180 ± 20 degrees
- Are willing to wear contact lenses in both eyes;
- Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;
- To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable.
Exclusion Criteria
- A person will be excluded from the study if they:
- Are participating in any concurrent clinical or research study;
- Have any known active* ocular disease and/or infection;
- Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Are aphakic;
- Have undergone refractive error surgery;
Data sourced from ClinicalTrials.gov (NCT02555098). 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.