Clinical trial NCT02410824: Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
Official title: Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 52
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Comfort
timeFrame: Baseline and 1 Week
measure: Handling
timeFrame: Baseline and 1 Week
measure: Vision
timeFrame: Baseline and 1 Week
measure: High Visual Acuity
timeFrame: Baseline and 1 Week
measure: Low Visual Acuity
timeFrame: Baseline and 1 Week
measure: Lens Surface - Wettability
timeFrame: Baseline and 1 Week
measure: Lens Surface - Deposits
timeFrame: Baseline and 1 Week
measure: Corneal Staining, Type
timeFrame: Baseline and 1 week
measure: Corneal Staining, Extent
timeFrame: Baseline and 1 week
measure: Conjunctival Staining
timeFrame: Baseline and 1 week
measure: Lens Durability
timeFrame: 1 Week
measure: Lens Fit Acceptance
timeFrame: Baseline and 1 Week
Secondary outcomes:
measure: Dryness
timeFrame: 1 Week
measure: Overall Satisfaction
timeFrame: Baseline and 1 week
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, University of California, Berkeley
state: California
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: UC Berkeley Clinical Research Center
name: Meng C Lin, OD PhD
role: PRINCIPAL_INVESTIGATOR
References: