Clinical trial NCT02542072: Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Official title: Multi-Center 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: 2015-09-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: 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 of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.

Detailed description: This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.

Eligibility criteria: Inclusion:

* Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
* Adapted soft Contact Lens wearers (i.e. \>1 month), daily disposable and reusable lens wearers.
* Spectacle cylinder 0.75D in both eyes.
* Correctable to 6/9 (20/30) in both eyes
* Be between 18 and 50 years of age (inclusive)
* Able to read, comprehend and sign an informed consent
* Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
* Willing to comply with the wear and study visit schedule

Exclusion:

* Existing Biofinity or Ultra wearers
* Any active corneal infection, injury or inflammation
* Systemic or ocular allergies, which might interfere with Contact Lens wear
* Systemic disease, which might interfere with Contact Lens wear
* Ocular disease, which might interfere with Contact Lens wear
* Strabismus or amblyopia
* Subjects who have undergone corneal refractive surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
* Pregnant or lactating
* Use of systemic/topical medication contraindicating Contact Lens wear
* Diabetic
* Site employees or family members of site employees

Primary outcomes:
measure: Comfort
timeFrame: Baseline, 2 weeks, 4 weeks
Secondary outcomes:
measure: Comfortable Wearing Time Via SMS (Short Message Service)
timeFrame: Days 3, 12, 26
measure: Wearing Times
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Deterioration in Comfort
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Vision Quality
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Overall Lens Handling
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Biomicroscopy Scores
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Lens Surface Wetting
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Film Deposits
timeFrame: 2 weeks and 4 weeks
measure: White Spot Deposits
timeFrame: 2 weeks and 4 weeks
measure: Visual Acuity (VA)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Lens Centration
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Corneal Coverage
timeFrame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
measure: Post-Blink Movement
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Primary Gaze Lag
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Lens Tightness Push-up
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Overall Fit Acceptance
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Dryness
timeFrame: Baseline, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Chew Magna
country: United Kingdom
facility: Brock & Houlford
state: Bristol
city: Broadstone
country: United Kingdom
facility: Tempany's Boutique Opticians
state: Dorset
city: Rawtenstall
country: United Kingdom
facility: David Gould Opticians
state: Lancashire
Study officials:
affiliation: VisionCare
name: Graeme Young
role: PRINCIPAL_INVESTIGATOR
References: