A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmat… (NCT02555098) | Clinical Trial Compass
CompletedNot Applicable
A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens
United States23 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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);
What they're measuring
1
Subjective Ratings for Comfort
Timeframe: Baseline (10 minutes post lens settling)
2
Subjective Ratings for Comfort
Timeframe: 2 weeks
3
Subjective Ratings for Comfort Preference
Timeframe: Baseline (10 minutes post lens settling)
4
Subjective Ratings for Comfort Preference
Timeframe: 2 weeks
5
Subjective Assessment of Visual Quality
Timeframe: Baseline (10 minutes post lens settling)
6
Subjective Assessment of Visual Quality
Timeframe: 2 weeks
7
Subjective Assessment of Overall Satisfaction
Timeframe: Baseline (10 minutes post lens settling)