Clinical trial NCT02956460: Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Official title: Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2016-11-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

Detailed description: The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.

Eligibility criteria: Inclusion Criteria:

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

* Is between 18 and 40 years of age (inclusive)
* Has read, understood and signed the information consent letter
* Has had a self-reported eye exam in the last two years
* Is a spherical soft contact lens wearer
* Has a contact lens prescription that fits within the available parameters of the study lenses
* Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses
* Has clear corneas and no active ocular disease
* Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
* Is willing and able to follow instructions and maintain the appointment schedule

Exclusion Criteria:

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

* Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; \>8 hours/day)
* Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
* Is habitually using rewetting/ lubricating eye drops more than once per day
* Presents with clinically significant anterior segment abnormalities
* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
* Presents with slit lamp findings 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 aphakia, keratoconus or a highly irregular cornea
* Has presbyopia or has dependence on spectacles for near work over the contact lenses
* Has undergone corneal refractive surgery

Primary outcomes:
measure: Overall Comfort
timeFrame: 2 weeks
measure: Overall Dryness
timeFrame: 2 weeks
measure: Vision Quality
timeFrame: 2 weeks
measure: Lens Handling
timeFrame: 2 weeks
measure: Vision Satisfaction
timeFrame: 2 weeks
measure: Lens Centration
timeFrame: 2 weeks
measure: Conjunctival Staining
timeFrame: 2 weeks
measure: Smoothness
timeFrame: 2 weeks
measure: Clean Feeling
timeFrame: 2 weeks
measure: Lens Hydrated
timeFrame: 2 weeks
measure: Lens Wettability
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Eric M. White O. D., Inc
state: California
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: State College
country: United States
facility: Nittany Eye Associates
state: Pennsylvania
Study officials:
affiliation: Centre for Contact Lens Research
name: Lyndon Jones, PhD, FAAO
role: STUDY_DIRECTOR
References: