Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01707238
First received: September 21, 2012
Last updated: August 25, 2014
Last verified: August 2014

September 21, 2012
August 25, 2014
October 2012
January 2013   (final data collection date for primary outcome measure)
  • Handling [ Time Frame: two weeks and four weeks from baseline visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: two weeks and four weeks from baseline visit ] [ Designated as safety issue: No ]
    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).
Lens handling [ Time Frame: after 2 weeks of lens wear ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01707238 on ClinicalTrials.gov Archive Site
  • Comfort [ Time Frame: two weeks and four weeks from baseline visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: two weeks and four weeks from baseline visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: two weeks and four weeks from baseline visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: two weeks and four weeks from baseline visit ] [ Designated as safety issue: No ]
    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).
Not Provided
Not Provided
Not Provided
 
Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Myopia
  • 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 Name: etafilcon A (Daily Disposable Contact Lens)
  • 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 Name: stenfilcon A (Daily Disposable Contact Lens)
  • 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.
    Intervention: Device: etafilcon A
  • 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.
    Intervention: Device: stenfilcon A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
16 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01707238
EX-MKTG-39
Yes
Coopervision, Inc.
Coopervision, Inc.
Not Provided
Study Director: Graeme Young Visioncare Research Ltd.
Study Director: Ruth Craven Visioncare Research Ltd.
Coopervision, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP