Clinical trial NCT03372551: Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens
Official title: Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2017-12-13
Enrollment: 36
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.

Detailed description: The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

Eligibility criteria: Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has had a self-reported oculo-visual examination in the last two years;
* Has read, understood, and signed the information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
* Must be able to achieve 20/30 or better (in each eye) with the study lenses;
* Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
* Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
* Has no more than 0.75 diopters of refractive astigmatism;
* Has clear corneas and no active\* ocular disease;
* Has not worn lenses for at least 12 hours before the examination.

Exclusion Criteria:

* Is presently participating in any other clinical or research study including eye related clinical or research study;
* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Has any active\* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
* Has any known sensitivity to fluorescein dye or products to be used in the study.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

Primary outcomes:
measure: Comfort
timeFrame: up to 1 week
measure: Preference
timeFrame: up to 1 week
measure: Vision
timeFrame: Up to 1 week
measure: Subjective Vision
timeFrame: up to 1 week
measure: Corneal Staining
timeFrame: up to 1 week
measure: Conjunctival Staining
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
References: