Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

Myopia Clinical Trial

Official title:

Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542072
• Other study ID #: EX-MKTG-59 (VISA-406)
• Status: Completed
• Phase: N/A
• First received: August 31, 2015
• Last updated: September 21, 2017
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2017
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• comfilcon A
contact lens
• samfilcon A
contact lens

Locations

Country	Name	City	State
United Kingdom	Tempany's Boutique Opticians	Broadstone	Dorset
United Kingdom	Brock & Houlford	Chew Magna	Bristol
United Kingdom	David Gould Opticians	Rawtenstall	Lancashire
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).	Baseline, 2 weeks, 4 weeks
Secondary	Comfortable Wearing Time Via SMS (Short Message Service)	Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).	Days 3, 12, 26
Secondary	Wearing Times	Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.	Baseline, 2 weeks, 4 weeks
Secondary	Deterioration in Comfort	Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent	Baseline, 2 weeks, 4 weeks
Secondary	Vision Quality	Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.	Baseline, 2 weeks, 4 weeks
Secondary	Overall Lens Handling	Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.	Baseline, 2 weeks, 4 weeks
Secondary	Biomicroscopy Scores	Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe	Baseline, 2 weeks, 4 weeks
Secondary	Lens Surface Wetting	Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent	Baseline, 2 weeks, 4 weeks
Secondary	Film Deposits	Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.	2 weeks and 4 weeks
Secondary	White Spot Deposits	Number of white spot deposits for comfilcon A and samfilcon A lenses.	2 weeks and 4 weeks
Secondary	Visual Acuity (VA)	Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.	Baseline, 2 weeks, 4 weeks
Secondary	Lens Centration	Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm)	Baseline, 2 weeks, 4 weeks
Secondary	Corneal Coverage	Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes.; Yes = coverage at all times or No = coverage incomplete	Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Secondary	Post-Blink Movement	Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement	Baseline, 2 weeks, 4 weeks
Secondary	Primary Gaze Lag	Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement	Baseline, 2 weeks, and 4 weeks
Secondary	Lens Tightness Push-up	Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses.; Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support	Baseline, 2 weeks, 4 weeks
Secondary	Overall Fit Acceptance	Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect	Baseline, 2 weeks, 4 weeks
Secondary	Dryness	Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry	Baseline, 2 weeks, 4 weeks