Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: stenfilcon A toric lens; Device: etafilcon A toric lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02410824

CV-15-02

Details and patient eligibility

About

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Full description

CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.

Enrollment: 52 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

stenfilcon A toric lens

Experimental group

Description:

Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.

Treatment:

Device: stenfilcon A toric lens

etafilcon A toric lens

Active Comparator group

Description:

Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.

Treatment:

Device: etafilcon A toric lens