Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: senofilcon A; Device: fanfilcon A

• Registration Number: NCT02956460
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study Start: 2016-10-27
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Primary Completion: 2016-12-14
• Study Completion: 2016-12-14
• Results First Submitted: 2017-11-10
• Results First Submitted QC: 2017-11-10
• Results First Posted: 2017-12-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
senofilcon A	senofilcon A	Participants are randomized to wear senofilcon A for two weeks during the cross over study.
fanfilcon A	fanfilcon A	Participants are randomized to wear fanfilcon A for two weeks during the cross over study.

Primary Outcome Measures

Name	Time	Method
Lens Hydrated	2 weeks	Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
Vision Satisfaction	2 weeks	Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Overall Dryness	2 weeks	Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
Conjunctival Staining	2 weeks	Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification.; 0=None, no staining present; 1. Very slight; 2. Slight; 3. Moderate; 4. Severe
Vision Quality	2 weeks	Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear
Lens Handling	2 weeks	Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle
Overall Comfort	2 weeks	Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
Smoothness	2 weeks	Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth
Lens Centration	2 weeks	Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
Clean Feeling	2 weeks	Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean
Lens Wettability	2 weeks	Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable

Trial Locations

Locations (4)

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States

Eric M. White O. D., Inc; 🇺🇸 San Diego, California, United States

Golden Vision; 🇺🇸 Sarasota, Florida, United States

Nittany Eye Associates; 🇺🇸 State College, Pennsylvania, United States