Performance Comparison Between Comfilcon A and Senofilcon C Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: comfilcon A; Device: senofilcon C

• Registration Number: NCT02920957
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Primary Completion: 2016-11-23
• Study Completion: 2016-11-23
• Results First Submitted: 2017-10-09
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-11
• Last Update Submitted: 2017-12-11
• Results First Posted: 2018-01-09
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
comfilcon A	comfilcon A	Participants are randomized to wear the comfilcon A lens for one month during the cross over study.
senofilcon C	senofilcon C	Participants are randomized to wear the senofilcon C lens for one month during the cross over study.

Primary Outcome Measures

Name	Time	Method
Lens Lag at Primary Gaze	Up to 1 month	Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)
Post-blink Movement	Up to 1 month	Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)
Corneal Coverage	Up to 1 month	Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)
Lens Centration	Up to 1 month	Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)
Lens Wettability	Up to 1 month	Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)
Deposit Grading	Up to 1 month	Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)
Overall Lens Fit Acceptance	Up to 1 month	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.
Tightness on Push up	Up to 1 month	Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)

Trial Locations

Locations (5)

Sacco Eye Group; 🇺🇸 Vestal, New York, United States

Golden Optometric Group; 🇺🇸 Whittier, California, United States

Coan Eye Care & Optical Boutique; 🇺🇸 Ocoee, Florida, United States

Cornea & Contact Lens Institute of Minnesota; 🇺🇸 Edina, Minnesota, United States

Vision Professionals; 🇺🇸 New Albany, Ohio, United States