Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Myopia Clinical Trial

Official title:

Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956460
• Other study ID #: EX-MKTG-73
• Status: Completed
• Phase: N/A
• First received: November 3, 2016
• Last updated: March 6, 2018
• Start date: October 27, 2016
• Est. completion date: December 14, 2016

Study information

• Verified date: March 2018
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 14, 2016
• Est. primary completion date: December 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• fanfilcon A
contact lens
• senofilcon A
contact lens

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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