Performance Comparison Between Comfilcon A and Senofilcon C Lenses

Myopia Clinical Trial

Official title:

Performance Comparison Between Comfilcon A and Senofilcon C Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920957
• Other study ID #: EX-MKTG-70
• Status: Completed
• Phase: N/A
• First received: September 29, 2016
• Last updated: December 11, 2017
• Start date: September 2016
• Est. completion date: November 23, 2016

Study information

• Verified date: December 2017
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 23, 2016
• Est. primary completion date: November 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• comfilcon A
contact lens
• senofilcon C
contact lens

Locations

Country	Name	City	State
United States	Cornea & Contact Lens Institute of Minnesota	Edina	Minnesota
United States	Vision Professionals	New Albany	Ohio
United States	Coan Eye Care & Optical Boutique	Ocoee	Florida
United States	Sacco Eye Group	Vestal	New York
United States	Golden Optometric Group	Whittier	California

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 Lens Fit Acceptance	Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.	Up to 1 month
Primary	Corneal Coverage	Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)	Up to 1 month
Primary	Lens Centration	Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)	Up to 1 month
Primary	Post-blink Movement	Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)	Up to 1 month
Primary	Lens Lag at Primary Gaze	Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)	Up to 1 month
Primary	Tightness on Push up	Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)	Up to 1 month
Primary	Lens Wettability	Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)	Up to 1 month
Primary	Deposit Grading	Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)	Up to 1 month