Clinical trial NCT01809834: Evaluation of Stenfilcon A Versus Etafilcon A
Official title: Evaluation of Stenfilcon A Versus Etafilcon A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 46
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluation of two contact lenses

Detailed description: One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

Eligibility criteria: Inclusion Criteria:

* Is at least 17 years of age 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 correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
* Has astigmatism less than or equal to -1.00D;
* Is an adapted soft contact lens wearer;
* Demonstrates an acceptable fit with the study lenses;
* Has no active anterior segment disease or known ocular disease.

Exclusion Criteria:

* A person will be excluded from the study if he/she:
* Has never worn contact lenses before;
* Has any systemic disease affecting ocular health;
* Is using any systemic or topical medications that will affect ocular health;
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses;
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;
* Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
* Is aphakic;
* Has undergone corneal refractive surgery;
* Is participating in any other type of clinical or research study;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

Primary outcomes:
measure: Participant's Subjective Rating of Comfort (Questionnaire)
timeFrame: Insertion, After Lens settling, 12-hours, 1-week
measure: Participant's Subjective Rating of Dryness (Questionnaire)
timeFrame: 12-hours, 1-week
measure: Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)
timeFrame: Dispense
measure: Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
timeFrame: 12-hours, 1-week
measure: Participant's Subjective Rating of Visual Quality (Questionnaire)
timeFrame: 12-hours, 1-week
measure: Participant's Subjective Rating of Overall Preference (Questionnaire)
timeFrame: 12-hours, 1-week
Secondary outcomes:
measure: Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
timeFrame: Insertion, 12 hours, 1 week
measure: Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
timeFrame: Insertion, 12 hours, 1 week
measure: Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
timeFrame: Insertion
measure: Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
timeFrame: Insertion, 12-hours, 1-week
measure: Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
timeFrame: Baseline, 12-hours, 1-week
measure: Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
timeFrame: Baseline, 12-hours, 1-week
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: Univeristy of Waterloo, Canada
name: Lyndon Jones, PhD., FCO
role: PRINCIPAL_INVESTIGATOR
References: