NCT02815735

Brief Summary

The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

9 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

First Submitted

Initial submission to the registry

June 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 8, 2017

Completed
Last Updated

May 8, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

June 24, 2016

Results QC Date

March 28, 2017

Last Update Submit

March 28, 2017

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Comfort

    Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.

    Baseline, 2 weeks, 4 weeks

  • Comfort During the Day

    Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.

    Days 3, 12, 26

Study Arms (2)

comfilcon A

EXPERIMENTAL

Participants wear comfilcon A lens for 4 weeks during the cross over study.

Device: comfilcon A

lotrafilcon B

ACTIVE COMPARATOR

Participants wear lotrafilcon B lens for 4 weeks during the cross over study.

Device: lotrafilcon B

Interventions

comfilcon ADEVICE

contact lens

comfilcon A
lotrafilcon BDEVICE

contact lens

lotrafilcon B

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)
  • Adapted soft CL wearers (i.e. \>1 month) who are reusable lens wearers\*
  • Spectacle cylinder 0.75D in both eyes
  • Correctable to 6/9 in both eyes
  • Be between 18 and 34 years of age (inclusive)
  • Able to read, comprehend and sign an informed consent
  • Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm
  • Willing to comply with the wear and study visit schedule

You may not qualify if:

  • Existing wearer of daily disposable contact lenses
  • Known allergy to Opti-Free PureMoist multipurpose solution
  • Any active corneal infection, injury or inflammation
  • Systemic or ocular allergies, which might interfere with CL wear
  • Systemic disease, which might interfere with CL wear
  • Ocular disease, which might interfere with CL wear
  • Strabismus or amblyopia
  • Subjects who have undergone corneal refractive surgery
  • Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
  • Pregnant, planning a pregnancy or lactating
  • Use of systemic/topical medication contraindicating CL wear
  • Diabetic
  • Site employees or family members of investigators
  • Participation in any concurrent trial or in the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Eyesite

Reading, Berkshire, RG1 1EX, United Kingdom

Location

Brock and Houlford

Chew Magna, Bristol, BS40 8PR, United Kingdom

Location

Tempany's Boutique Opticians

Broadstone, Dorset, BH18 8DP, United Kingdom

Location

Chalmers Opticians

Cardiff, Glamorgan, CF24 3RQ, United Kingdom

Location

Leightons

St Albans, Hertfordshire, AL1 3LH, United Kingdom

Location

David Gould Opticians

Rawtenstall, Lancashire, BB4 7QN, United Kingdom

Location

Harrold Opticians

Uxbridge, Middlesex, UB8 1JX, United Kingdom

Location

Boots Opticians Ltd

Birmingham, Warwickshire, B4 7TB, United Kingdom

Location

Visioncare Research Ltd.

Farnham, GU9 7EN, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

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

Study Officials

  • Graeme Young

    Visioncare Research Ltd.

    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

June 24, 2016

First Posted

June 28, 2016

Study Start

August 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

May 8, 2017

Results First Posted

May 8, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(9)