NCT02759471

Brief Summary

This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 23, 2017

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

April 29, 2016

Results QC Date

January 3, 2017

Last Update Submit

July 19, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

  • Lens Fit - Centration

    Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).

    baseline, 2 weeks, 1 month

  • Lens Fit - Corneal Coverage

    Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).

    baseline, 2 weeks, 1 month

  • Lens Fit - Post-blink Movement

    Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

    baseline, 2 weeks, 1 month

  • Lens Preference/Acceptability

    Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).

    baseline, 2 weeks, 1 month

Study Arms (2)

comfilcon A asphere (test)

EXPERIMENTAL

Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).

Device: comfilcon A asphere lens (test)

comfilcon A sphere (control)

ACTIVE COMPARATOR

Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).

Device: comfilcon A sphere lens (control)

Interventions

comfilcon A sphere lens (control)DEVICE

contact lens

comfilcon A sphere (control)
comfilcon A asphere lens (test)DEVICE

contact lens

comfilcon A asphere (test)

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 an adapted comfilcon A sphere contact lens wearer
  • Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
  • 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 refraction that fits within the available parameters of the study lenses.
  • Is willing to comply with the wear schedule (at least 5 days per week, \> 8 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 (5 days per week; \> 8 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Golden Optometric Group

Whittier, California, 90606, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Drs. Quinn, Foster, & Associates

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Senior Manager Global Medical Scientific Affairs
Organization
CooperVision
javega@coopervision.com
1-925-621-3761

Study Officials

  • Andrew Sacco, OD

    Sacco Eye Group

    PRINCIPAL INVESTIGATOR

  • Gina Wesley, OD

    Complete Eye Care of Medina

    PRINCIPAL INVESTIGATOR

  • Thomas Quinn, OD, MS, FAAO

    Drs. Quinn, Foster, & Associates

    PRINCIPAL INVESTIGATOR

  • David Ardaya, OD

    Golden Optometric Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 3, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

July 29, 2020

Results First Posted

February 23, 2017

Record last verified: 2020-07

Locations

US(4)