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Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

Primary Purpose

Myopia

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

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:-

  • Be between 16 and 45 years of age (inclusive)
  • Adapted soft contact lens (CL) wearers (i.e. > 1 month)
  • Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
  • Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
  • Correctable to 6/9 (20/30) in both eyes
  • Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
  • Have read, understood and signed the informed consent
  • Willing to comply with the wear schedule (at least 40 hours per week)
  • Willing to comply with the study visit schedule

Exclusion Criteria:-

  • 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, amblyopia
  • Subjects who have undergone corneal refractive surgery and any anterior segment surgery
  • Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
  • Pregnant or lactating
  • Use of systemic/topical medication contraindicating CL wear
  • Use of gas permeable contact lenses within the last month
  • Employees of the investigational site or immediate family members of Investigators
  • Participation in any concurrent clinical trial or in the last 30 days

Sites / Locations

  • Keith Tempany Opticians
  • Cameron-Davies Optometrists
  • Cameron-Davies Optometrists
  • Leightons Opticians
  • David Gould Opticians
  • Vision Express Optical Lab
  • S.H. Harrold

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stenfilcon A

etafilcon A

Arm Description

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Outcomes

Primary Outcome Measures

Handling
Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).
Satisfaction With Handling
Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).

Secondary Outcome Measures

Comfort
Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).
Dryness
Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).
Satisfaction With Dryness
Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
Satisfaction With Comfort
Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).

Full Information

First Posted
September 21, 2012
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01707238
Brief Title
Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
Official Title
Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.
Detailed Description
The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.

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
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stenfilcon A
Arm Type
Experimental
Arm Description
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Arm Title
etafilcon A
Arm Type
Active Comparator
Arm Description
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Intervention Type
Device
Intervention Name(s)
etafilcon A
Other Intervention Name(s)
etafilcon A (Daily Disposable Contact Lens)
Intervention Description
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Intervention Type
Device
Intervention Name(s)
stenfilcon A
Other Intervention Name(s)
stenfilcon A (Daily Disposable Contact Lens)
Intervention Description
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Primary Outcome Measure Information:
Title
Handling
Description
Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).
Time Frame
two weeks and four weeks from baseline visit
Title
Satisfaction With Handling
Description
Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
Time Frame
two weeks and four weeks from baseline visit
Secondary Outcome Measure Information:
Title
Comfort
Description
Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).
Time Frame
two weeks and four weeks from baseline visit
Title
Dryness
Description
Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).
Time Frame
two weeks and four weeks from baseline visit
Title
Satisfaction With Dryness
Description
Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
Time Frame
two weeks and four weeks from baseline visit
Title
Satisfaction With Comfort
Description
Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
Time Frame
two weeks and four weeks from baseline visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- Be between 16 and 45 years of age (inclusive) Adapted soft contact lens (CL) wearers (i.e. > 1 month) Spherical distance CL prescription between -1.00 and -6.00D (inclusive) Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other. Correctable to 6/9 (20/30) in both eyes Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study. Have read, understood and signed the informed consent Willing to comply with the wear schedule (at least 40 hours per week) Willing to comply with the study visit schedule Exclusion Criteria:- 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, amblyopia Subjects who have undergone corneal refractive surgery and any anterior segment surgery Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear Pregnant or lactating Use of systemic/topical medication contraindicating CL wear Use of gas permeable contact lenses within the last month Employees of the investigational site or immediate family members of Investigators Participation in any concurrent clinical 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
First Name & Middle Initial & Last Name & Degree
Ruth Craven
Organizational Affiliation
Visioncare Research Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Keith Tempany Opticians
City
Broadstone
State/Province
Dorset
ZIP/Postal Code
MH18
Country
United Kingdom
Facility Name
Cameron-Davies Optometrists
City
Southsea
State/Province
Hampshire
ZIP/Postal Code
PO5 2AT
Country
United Kingdom
Facility Name
Cameron-Davies Optometrists
City
Portchester
State/Province
Hants
ZIP/Postal Code
PO16 9UN
Country
United Kingdom
Facility Name
Leightons Opticians
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
Vision Express Optical Lab
City
Hendon
State/Province
London
ZIP/Postal Code
NW4 3FB
Country
United Kingdom
Facility Name
S.H. Harrold
City
Uxbridge
State/Province
London
ZIP/Postal Code
UB8 1JX
Country
United Kingdom

12. IPD Sharing Statement

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Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

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