Clinical trial NCT02920957: Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Official title: Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2016-09-30
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

Detailed description: This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.

Eligibility criteria: Inclusion Criteria:

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

* Is between 18 and 34 years of age (inclusive)
* Has had a self-reported eye exam in the last two years
* Is a spherical soft contact lens wearer
* Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
* 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
* Has read, understood and signed the information consent letter.
* Has a contact lens prescription that fits within the available parameters of the study lenses.
* Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit 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 6 days per week; \> 10 hours/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.
* Is participating in any other type of eye related clinical or research study.
* Is habitually using rewetting/ lubricating eye drops more than once per day
* Is currently wearing daily disposable lenses

Primary outcomes:
measure: Overall Lens Fit Acceptance
timeFrame: Up to 1 month
measure: Corneal Coverage
timeFrame: Up to 1 month
measure: Lens Centration
timeFrame: Up to 1 month
measure: Post-blink Movement
timeFrame: Up to 1 month
measure: Lens Lag at Primary Gaze
timeFrame: Up to 1 month
measure: Tightness on Push up
timeFrame: Up to 1 month
measure: Lens Wettability
timeFrame: Up to 1 month
measure: Deposit Grading
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Ocoee
country: United States
facility: Coan Eye Care & Optical Boutique
state: Florida
city: Edina
country: United States
facility: Cornea & Contact Lens Institute of Minnesota
state: Minnesota
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: New Albany
country: United States
facility: Vision Professionals
state: Ohio
Study officials:
affiliation: Centre for Contact Lens Research
name: Lyndon Jones, PhD, FAAO, FIACLE, FBCLA
role: STUDY_DIRECTOR
References: