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Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01707238
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : August 27, 2014
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myopia Device: etafilcon A Device: stenfilcon A Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
Study Start Date : October 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: stenfilcon A (Daily Disposable Contact Lens)


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707238


Locations
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United Kingdom
Keith Tempany Opticians
Broadstone, Dorset, United Kingdom, MH18
Cameron-Davies Optometrists
Southsea, Hampshire, United Kingdom, PO5 2AT
Cameron-Davies Optometrists
Portchester, Hants, United Kingdom, PO16 9UN
Leightons Opticians
St. Albans, Hertfordshire, United Kingdom, AL1 3LH
David Gould Opticians
Rawtenstall, Lancashire, United Kingdom, BB4 7QN
Vision Express Optical Lab
Hendon, London, United Kingdom, NW4 3FB
S.H. Harrold
Uxbridge, London, United Kingdom, UB8 1JX
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Study Director: Graeme Young Visioncare Research Ltd.
Study Director: Ruth Craven Visioncare Research Ltd.
More Information
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01707238    
Other Study ID Numbers: EX-MKTG-39
First Posted: October 16, 2012    Key Record Dates
Results First Posted: August 27, 2014
Last Update Posted: August 3, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases