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Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
comfilcon A
lotrafilcon B
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 34 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eyesite
  • Brock and Houlford
  • Tempany's Boutique Opticians
  • Chalmers Opticians
  • Leightons
  • David Gould Opticians
  • Harrold Opticians
  • Boots Opticians Ltd
  • Visioncare Research Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

comfilcon A

lotrafilcon B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2016
Last Updated
March 28, 2017
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02815735
Brief Title
Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
Official Title
Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comfilcon A
Arm Type
Experimental
Arm Description
Participants wear comfilcon A lens for 4 weeks during the cross over study.
Arm Title
lotrafilcon B
Arm Type
Active Comparator
Arm Description
Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
Intervention Type
Device
Intervention Name(s)
comfilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
lotrafilcon B
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Comfort
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Comfort During the Day
Description
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.
Time Frame
Days 3, 12, 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme Young
Organizational Affiliation
Visioncare Research Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Eyesite
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 1EX
Country
United Kingdom
Facility Name
Brock and Houlford
City
Chew Magna
State/Province
Bristol
ZIP/Postal Code
BS40 8PR
Country
United Kingdom
Facility Name
Tempany's Boutique Opticians
City
Broadstone
State/Province
Dorset
ZIP/Postal Code
BH18 8DP
Country
United Kingdom
Facility Name
Chalmers Opticians
City
Cardiff
State/Province
Glamorgan
ZIP/Postal Code
CF24 3RQ
Country
United Kingdom
Facility Name
Leightons
City
St Albans
State/Province
Hertfordshire
ZIP/Postal Code
AL1 3LH
Country
United Kingdom
Facility Name
David Gould Opticians
City
Rawtenstall
State/Province
Lancashire
ZIP/Postal Code
BB4 7QN
Country
United Kingdom
Facility Name
Harrold Opticians
City
Uxbridge
State/Province
Middlesex
ZIP/Postal Code
UB8 1JX
Country
United Kingdom
Facility Name
Boots Opticians Ltd
City
Birmingham
State/Province
Warwickshire
ZIP/Postal Code
B4 7TB
Country
United Kingdom
Facility Name
Visioncare Research Ltd.
City
Farnham
ZIP/Postal Code
GU9 7EN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

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