Clinical trial NCT03024970: Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens
Official title: Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2017-01-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

Detailed description: This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months.

Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

Eligibility criteria: Inclusion Criteria:

* A person is eligible for inclusion in the study if he/she:

  * 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.
  * Must achieve 20/30 or better (in each eye) with study lenses
  * Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
  * Has no more than 0.75 diopters of refractive astigmatism.
  * Currently wears soft contact lenses.
  * Have clear corneas and no active ocular disease.
  * Has not worn lenses for at least 12 hours before the examination

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, 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).
  * Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Primary outcomes:
measure: Subjective Ratings on Comfort
timeFrame: Baseline
measure: Subjective Ratings on Comfort
timeFrame: 1 Week
measure: Subjective Ratings on Comfort
timeFrame: 1 Month
measure: Vision Satisfaction
timeFrame: Baseline
measure: Vision Satisfaction
timeFrame: 1 week
measure: Vision Satisfaction
timeFrame: 1 Month
measure: Visual Acuity On High Illumination High Contrast
timeFrame: Baseline
measure: Visual Acuity On High Illumination High Contrast
timeFrame: 1 Week
measure: Visual Acuity On High Illumination High Contrast
timeFrame: 1 Month
measure: Visual Acuity On Low Illumination High Contrast
timeFrame: Baseline
measure: Visual Acuity On Low Illumination High Contrast
timeFrame: 1 Week
measure: Visual Acuity On Low Illumination High Contrast
timeFrame: 1 Month
measure: Overall Corneal Staining
timeFrame: One Week
measure: Overall Corneal Staining
timeFrame: One Month
measure: Conjunctival Staining
timeFrame: 1 Week
measure: Conjunctival Staining
timeFrame: 1 Month
measure: Bulbar Hyperemia
timeFrame: 1 Week
measure: Bulbar Hyperemia
timeFrame: 1 Month
measure: Limbal Hyperemia
timeFrame: 1 Week
measure: Limbal Hyperemia
timeFrame: 1 Month
measure: Palpebral Hyperemia
timeFrame: 1 Week
measure: Palpebral Hyperemia
timeFrame: 1 Month
Secondary outcomes:
measure: Lens Fit Acceptance
timeFrame: Baseline
measure: Lens Fit Acceptance
timeFrame: 1 week
measure: Lens Fit Acceptance
timeFrame: 1 Month
measure: Handling Satisfaction
timeFrame: 1 week
measure: Handling Satisfaction
timeFrame: 1 Month
measure: Lens Surface - Wettability
timeFrame: Baseline
measure: Lens Surface - Wettability
timeFrame: 1 Week
measure: Lens Surface - Wettability
timeFrame: 1 Month
measure: Lens Surface - Deposits
timeFrame: Baseline
measure: Lens Surface - Deposits
timeFrame: 1 week
measure: Lens Surface - Deposits
timeFrame: 1 Month
measure: Subjective Ratings on Dryness
timeFrame: Baseline
measure: Subjective Ratings on Dryness
timeFrame: 1 week
measure: Subjective Ratings on Dryness
timeFrame: 1 Month
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Clinical Optical Research Lab (CORL)
state: Indiana
city: Houston
country: United States
facility: The Ocular Surface Institute (TOSI)
state: Texas
Study officials:
affiliation: Clinical Optics Research Lab (CORL) Indiana University School of Optometry.
name: Pete Kollbaum, OD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Houston
name: Eric Ritchey, OD, PhD, FAAO
role: PRINCIPAL_INVESTIGATOR
References: