Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
- Conditions
- Myopia
- Interventions
- Device: etafilcon ADevice: stenfilcon A
- Registration Number
- NCT01707238
- Lead Sponsor
- Coopervision, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description stenfilcon A 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. etafilcon A 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.
- Primary Outcome Measures
Name Time Method Handling 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).
Satisfaction With Handling 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
Name Time Method Comfort 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).
Dryness 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).
Satisfaction With Dryness 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).
Satisfaction With Comfort 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).
Trial Locations
- Locations (6)
Leightons Opticians
🇬🇧St. Albans, Hertfordshire, United Kingdom
David Gould Opticians
🇬🇧Rawtenstall, Lancashire, United Kingdom
Vision Express Optical Lab
🇬🇧Hendon, London, United Kingdom
Cameron-Davies Optometrists
🇬🇧Portchester, Hants, United Kingdom
Keith Tempany Opticians
🇬🇧Broadstone, Dorset, United Kingdom
S.H. Harrold
🇬🇧Uxbridge, London, United Kingdom