Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

March 28, 2017 updated by: CooperVision, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Farnham, United Kingdom, GU9 7EN
        • Visioncare Research Ltd.
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 1EX
        • Eyesite
    • Bristol
      • Chew Magna, Bristol, United Kingdom, BS40 8PR
        • Brock and Houlford
    • Dorset
      • Broadstone, Dorset, United Kingdom, BH18 8DP
        • Tempany's Boutique Opticians
    • Glamorgan
      • Cardiff, Glamorgan, United Kingdom, CF24 3RQ
        • Chalmers Opticians
    • Hertfordshire
      • St Albans, Hertfordshire, United Kingdom, AL1 3LH
        • Leightons
    • Lancashire
      • Rawtenstall, Lancashire, United Kingdom, BB4 7QN
        • David Gould Opticians
    • Middlesex
      • Uxbridge, Middlesex, United Kingdom, UB8 1JX
        • Harrold Opticians
    • Warwickshire
      • Birmingham, Warwickshire, United Kingdom, B4 7TB
        • Boots Opticians Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: comfilcon A
Participants wear comfilcon A lens for 4 weeks during the cross over study.
Device: comfilcon A
contact lens
Active Comparator: lotrafilcon B
Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
Device: lotrafilcon B
contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: Baseline, 2 weeks, 4 weeks
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
Time Frame: Days 3, 12, 26
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CooperVision, Inc.

Investigators

  • Study Director: Graeme Young, Visioncare Research Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-MKTG-68 (VISA-407)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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