Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

July 19, 2020 updated by: CooperVision, Inc.
The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

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
    • Dorset
      • Broadstone, Dorset, United Kingdom, MH18
        • Keith Tempany Opticians
    • Hampshire
      • Southsea, Hampshire, United Kingdom, PO5 2AT
        • Cameron-Davies Optometrists
    • Hants
      • Portchester, Hants, United Kingdom, PO16 9UN
        • Cameron-Davies Optometrists
    • Hertfordshire
      • St. Albans, Hertfordshire, United Kingdom, AL1 3LH
        • Leightons Opticians
    • Lancashire
      • Rawtenstall, Lancashire, United Kingdom, BB4 7QN
        • David Gould Opticians
    • London
      • Hendon, London, United Kingdom, NW4 3FB
        • Vision Express Optical Lab
      • Uxbridge, London, United Kingdom, UB8 1JX
        • S.H. Harrold

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

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stenfilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Device: etafilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Other Names:
  • etafilcon A (Daily Disposable Contact Lens)
Active Comparator: etafilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Device: stenfilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Other Names:
  • stenfilcon A (Daily Disposable Contact Lens)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handling
Time Frame: two weeks and four weeks from baseline visit
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).
two weeks and four weeks from baseline visit
Satisfaction With Handling
Time Frame: two weeks and four weeks from baseline visit
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).
two weeks and four weeks from baseline visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: two weeks and four weeks from baseline visit
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).
two weeks and four weeks from baseline visit
Dryness
Time Frame: two weeks and four weeks from baseline visit
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).
two weeks and four weeks from baseline visit
Satisfaction With Dryness
Time Frame: two weeks and four weeks from baseline visit
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).
two weeks and four weeks from baseline visit
Satisfaction With Comfort
Time Frame: two weeks and four weeks from baseline visit
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).
two weeks and four weeks from baseline visit

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 Director: Ruth Craven, 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

October 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

October 12, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Actual)

August 3, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-MKTG-39

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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