NCT02542072

Brief Summary

The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

5 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

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 21, 2017

Completed
Last Updated

October 24, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

August 31, 2015

Results QC Date

January 30, 2017

Last Update Submit

September 21, 2017

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Comfort

    Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).

    Baseline, 2 weeks, 4 weeks

Secondary Outcomes (17)

  • Comfortable Wearing Time Via SMS (Short Message Service)

    Days 3, 12, 26

  • Wearing Times

    Baseline, 2 weeks, 4 weeks

  • Deterioration in Comfort

    Baseline, 2 weeks, 4 weeks

  • Vision Quality

    Baseline, 2 weeks, 4 weeks

  • Overall Lens Handling

    Baseline, 2 weeks, 4 weeks

  • +12 more secondary outcomes

Study Arms (2)

comfilcon A

ACTIVE COMPARATOR

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

Device: comfilcon A

samfilcon A

ACTIVE COMPARATOR

Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.

Device: samfilcon A

Interventions

comfilcon ADEVICE

contact lens

comfilcon A
samfilcon ADEVICE

contact lens

samfilcon A

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
  • Adapted soft Contact Lens wearers (i.e. \>1 month), daily disposable and reusable lens wearers.
  • Spectacle cylinder 0.75D in both eyes.
  • Correctable to 6/9 (20/30) in both eyes
  • Be between 18 and 50 years of age (inclusive)
  • Able to read, comprehend and sign an informed consent
  • Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
  • Willing to comply with the wear and study visit schedule

You may not qualify if:

  • Existing Biofinity or Ultra wearers
  • Any active corneal infection, injury or inflammation
  • Systemic or ocular allergies, which might interfere with Contact Lens wear
  • Systemic disease, which might interfere with Contact Lens wear
  • Ocular disease, which might interfere with Contact Lens wear
  • Strabismus or amblyopia
  • Subjects who have undergone corneal refractive surgery
  • Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
  • Pregnant or lactating
  • Use of systemic/topical medication contraindicating Contact Lens wear
  • Diabetic
  • Site employees or family members of site employees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Golden Optometric Group

Whittier, California, 90606, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Brock & Houlford

Chew Magna, Bristol, BS40 8PR, United Kingdom

Location

Tempany's Boutique Opticians

Broadstone, Dorset, BH18 8DP, United Kingdom

Location

David Gould Opticians

Rawtenstall, Lancashire, BB4 7QN, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Sr. Manager Global Medical Scientific Affairs
Organization
CooperVision Inc.
javega@coopervision.com
(925) 621-3761

Study Officials

  • Graeme Young

    VisionCare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 4, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

October 24, 2017

Results First Posted

March 21, 2017

Record last verified: 2017-09

Locations

GB(3)US(2)