Clinical trial NCT01707238: Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
Official title: Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Handling
timeFrame: two weeks and four weeks from baseline visit
measure: Satisfaction With Handling
timeFrame: two weeks and four weeks from baseline visit
Secondary outcomes:
measure: Comfort
timeFrame: two weeks and four weeks from baseline visit
measure: Dryness
timeFrame: two weeks and four weeks from baseline visit
measure: Satisfaction With Dryness
timeFrame: two weeks and four weeks from baseline visit
measure: Satisfaction With Comfort
timeFrame: two weeks and four weeks from baseline visit
Other outcomes:
Locations:
city: Broadstone
country: United Kingdom
facility: Keith Tempany Opticians
state: Dorset
city: Southsea
country: United Kingdom
facility: Cameron-Davies Optometrists
state: Hampshire
city: Portchester
country: United Kingdom
facility: Cameron-Davies Optometrists
state: Hants
city: St. Albans
country: United Kingdom
facility: Leightons Opticians
state: Hertfordshire
city: Rawtenstall
country: United Kingdom
facility: David Gould Opticians
state: Lancashire
city: Hendon
country: United Kingdom
facility: Vision Express Optical Lab
state: London
city: Uxbridge
country: United Kingdom
facility: S.H. Harrold
state: London
Study officials:
affiliation: Visioncare Research Ltd.
name: Graeme Young
role: STUDY_DIRECTOR
affiliation: Visioncare Research Ltd.
name: Ruth Craven
role: STUDY_DIRECTOR
References: