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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)