Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism (NCT02410824) | Clinical Trial Compass
CompletedNot Applicable
Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
United States, Canada52 participantsStarted 2015-04
Plain-language summary
Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.
Who can participate
Age range17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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