N/A
N=45
Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT02410824 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Comfort — 88; 78; 85; 77 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- stenfilcon A toric lens (Device); etafilcon A toric lens (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort |
88; 78; 85; 77 | — |
| PRIMARY Handling |
87; 81; 87; 81 | — |
| PRIMARY Vision |
83; 78; 86; 83 | — |
| PRIMARY High Visual Acuity |
-0.10; -0.08; -0.09; -0.09 | — |
| PRIMARY Low Visual Acuity |
-0.08; -0.07; -0.07; -0.07 | — |
| PRIMARY Lens Surface - Wettability |
3.2; 3.4; 3.2; 3.3 | — |
| PRIMARY Lens Surface - Deposits |
0.09; 0.11; 0.18; 0.25 | — |
| PRIMARY Corneal Staining, Type |
0.09; 0.09; 0.07; 0.02; 0.19; 0.19 | — |
| PRIMARY Corneal Staining, Extent |
0.07; 0.07; 0.07; 0.01; 0.13; 0.13 | — |
| PRIMARY Conjunctival Staining |
0.36; 0.36; 1.19; 1.49; 0.28; 0.28 | — |
| PRIMARY Lens Durability |
1; 0 | — |
| PRIMARY Lens Fit Acceptance |
3.5; 3.4; 3.5; 3.3 | — |
| SECONDARY Dryness |
82; 74; 76; 67 | — |
| SECONDARY Overall Satisfaction |
87; 80; 83; 77 | — |
Summary
Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is an adapted soft contact lens wearer;
- Requires a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye
- Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes);
- Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week;
- Has manifest refraction visual acuities (VA) equal to or better than logMAR 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 as acceptable.
Exclusion Criteria
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- 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 a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery
Data sourced from ClinicalTrials.gov (NCT02410824). 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.