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
  Purpose

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 Intervention Phase
Myopia
Device: etafilcon A
Device: stenfilcon A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

Resource links provided by NLM:


Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 100
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707238

Locations
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
Study Director: Graeme Young Visioncare Research Ltd.
Study Director: Ruth Craven Visioncare Research Ltd.
  More Information

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01707238     History of Changes
Other Study ID Numbers: EX-MKTG-39
Study First Received: September 21, 2012
Results First Received: April 1, 2014
Last Updated: August 25, 2014
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on October 21, 2014