Clinical trial NCT02815735: Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
Official title: Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.

Detailed description: This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.

Eligibility criteria: Inclusion Criteria:

* Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)
* Adapted soft CL wearers (i.e. \>1 month) who are reusable lens wearers\*
* Spectacle cylinder 0.75D in both eyes
* Correctable to 6/9 in both eyes
* Be between 18 and 34 years of age (inclusive)
* Able to read, comprehend and sign an informed consent
* Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm
* Willing to comply with the wear and study visit schedule

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

* Existing wearer of daily disposable contact lenses
* Known allergy to Opti-Free PureMoist multipurpose solution
* 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 or amblyopia
* Subjects who have undergone corneal refractive surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
* Pregnant, planning a pregnancy or lactating
* Use of systemic/topical medication contraindicating CL wear
* Diabetic
* Site employees or family members of investigators
* Participation in any concurrent trial or in the last 30 days

Primary outcomes:
measure: Comfort
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Comfort During the Day
timeFrame: Days 3, 12, 26
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Eyesite
state: Berkshire
city: Chew Magna
country: United Kingdom
facility: Brock and Houlford
state: Bristol
city: Broadstone
country: United Kingdom
facility: Tempany's Boutique Opticians
state: Dorset
city: Cardiff
country: United Kingdom
facility: Chalmers Opticians
state: Glamorgan
city: St Albans
country: United Kingdom
facility: Leightons
state: Hertfordshire
city: Rawtenstall
country: United Kingdom
facility: David Gould Opticians
state: Lancashire
city: Uxbridge
country: United Kingdom
facility: Harrold Opticians
state: Middlesex
city: Birmingham
country: United Kingdom
facility: Boots Opticians Ltd
state: Warwickshire
city: Farnham
country: United Kingdom
facility: Visioncare Research Ltd.
Study officials:
affiliation: Visioncare Research Ltd.
name: Graeme Young
role: STUDY_DIRECTOR
References: