Clinical trial NCT03951610: A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.
Official title: A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-05-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: 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 compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

Detailed description: The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.

Eligibility criteria: Inclusion Criteria:

* Has had a self-reported oculo-visual examination in the last two years.
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
* Requires spectacle lens spherical powers between -1.00 to -5.75 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.
* Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

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 enrollment (by verbal confirmation at the screening visit).

Primary outcomes:
measure: Number of Participants With Lens Centration
timeFrame: Baseline
measure: Number of Participants With Lens Centration
timeFrame: 1 week
measure: Post Blink Movement
timeFrame: Baseline
measure: Post Blink Movement
timeFrame: 1 week
measure: Primary Gaze Lag
timeFrame: baseline
measure: Primary Gaze Lag
timeFrame: 1 week
measure: Up Gaze Lag
timeFrame: Baseline
measure: Up Gaze Lag
timeFrame: 1 week
measure: Push-Up Tightness
timeFrame: baseline
measure: Push-Up Tightness
timeFrame: 1 week
measure: Overall Fit Acceptance
timeFrame: Baseline
measure: Overall Fit Acceptance
timeFrame: 1 week
measure: Number of Participants With Overall Lens Fit Impression
timeFrame: Baseline
measure: Number of Participants With Overall Lens Fit Impression
timeFrame: 1 week
Secondary outcomes:
measure: Subjective Comfort Rating
timeFrame: Baseline
measure: Subjective Comfort Rating
timeFrame: 1-week
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: University Eye Center at Ketchum Health
state: California
city: Bloomington
country: United States
facility: Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
state: Indiana
Study officials:
References: