Performance Comparison Between Comfilcon A and Senofilcon C Lenses

NCT02920957 | Completed Results

• 1 other identifier: EX-MKTG-70
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (8)

• 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

• Corneal Coverage

  Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)

  Up to 1 month

• Lens Centration

  Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)

  Up to 1 month

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

comfilcon A

ACTIVE COMPARATOR

Participants are randomized to wear the comfilcon A lens for one month during the cross over study.

Device: comfilcon A

senofilcon C

ACTIVE COMPARATOR

Participants are randomized to wear the senofilcon C lens for one month during the cross over study.

Device: senofilcon C

Interventions

comfilcon A DEVICE

contact lens

comfilcon A

senofilcon C DEVICE

contact lens

senofilcon C

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (5)

Golden Optometric Group

Whittier, California, 90606, United States

Location

Coan Eye Care & Optical Boutique

Ocoee, Florida, 34761, United States

Location

Cornea & Contact Lens Institute of Minnesota

Edina, Minnesota, 55436, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Vision Professionals

New Albany, Ohio, 43054, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Sr.Manager Global Medical Scientific Affairs
• Organization: CooperVision Inc

javega@coopervision.com

(925) 621-3761

Study Officials

• Lyndon Jones, PhD, FAAO, FIACLE, FBCLA

  Centre for Contact Lens Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: September 1, 2016
• Primary Completion: November 23, 2016
• Study Completion: November 23, 2016
• Last Updated: January 9, 2018
• Results First Posted: January 9, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)