Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 100
- Locations
- 7
- Primary Endpoint
- Handling
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 16 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: etafilcon A (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.
Intervention: stenfilcon A (Device)
Outcomes
Primary Outcomes
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).
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 Outcomes
- Comfort(two weeks and four weeks from baseline visit)
- Dryness(two weeks and four weeks from baseline visit)
- Satisfaction With Dryness(two weeks and four weeks from baseline visit)
- Satisfaction With Comfort(two weeks and four weeks from baseline visit)