Clinical trial NCT03496701: Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses
Official title: Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-04-12
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.

Detailed description: This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.

Eligibility criteria: Inclusion Criteria:

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

* Is between 18 and 35 years of age (inclusive)
* Has read and signed the informed consent letter
* Is willing and anticipated to follow instructions and maintain the appointment schedule
* Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.
* Habitually wears or is able to be adequately refit into MyDay Sphere lenses
* Demonstrates an acceptable fit with the study lenses
* Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses
* Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
* Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye
* Has clear corneas and no active ocular disease
* Has a contact lens refraction that fits within the available parameters of the study lenses.

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Is participating in any concurrent clinical research study
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has a systemic condition that, in the opinion of the investigator, may affect the study measures
* Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
* Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Significant pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (or history in past year)
  * Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study
* Has aphakia, keratoconus or a highly irregular cornea.
* Has presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone refractive surgery.
* Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment
* Has participated in any other type of eye related clinical or research study within the last 7 days
* Is habitually using rewetting/ lubricating eye drops (more than once per day)

Primary outcomes:
measure: Overall Lens Fit Acceptance
timeFrame: Baseline (After 10 minutes of lens dispense)
measure: Overall Lens Fit Acceptance
timeFrame: 1 week on each study lenses
Secondary outcomes:
measure: Lens Centration
timeFrame: Baseline - After 10 minutes of lens dispense
measure: Lens Centration
timeFrame: 1 week on each study lenses
measure: Post-blink Movement
timeFrame: Baseline (after 10 minutes of lens dispense)
measure: Post-blink Movement
timeFrame: 1 week on each study lenses
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Eric White, O.D., Inc.
state: California
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: State College
country: United States
facility: Nittany Eye Associates
state: Pennsylvania
Study officials:
affiliation: Golden Optometric Group, CA
name: David Ardaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Kannarr Eye Care, KS
name: Shane Kannarr
role: PRINCIPAL_INVESTIGATOR
affiliation: Nittany Eye Associates, PA
name: Michael Cymbor
role: PRINCIPAL_INVESTIGATOR
affiliation: Golden Vision, FL
name: Wayne Golden
role: PRINCIPAL_INVESTIGATOR
affiliation: CA
name: Eric M. White
role: PRINCIPAL_INVESTIGATOR
References: