Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: lotrafilcon B; Device: comfilcon A

• Registration Number: NCT02815735
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Study Start: 2016-08
• Primary Completion: 2017-01
• Study Completion: 2017-02
• Status Verified: 2017-03
• Results First Submitted: 2017-03-28
• Results First Submitted QC: 2017-03-28
• Last Update Submitted: 2017-03-28
• Results First Posted: 2017-05-08
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
lotrafilcon B	lotrafilcon B	Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
comfilcon A	comfilcon A	Participants wear comfilcon A lens for 4 weeks during the cross over study.

Primary Outcome Measures

Name	Time	Method
Comfort During the Day	Days 3, 12, 26	Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.
Comfort	Baseline, 2 weeks, 4 weeks	Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.

Trial Locations

Locations (9)

Eyesite; 🇬🇧 Reading, Berkshire, United Kingdom

Visioncare Research Ltd.; 🇬🇧 Farnham, United Kingdom

Brock and Houlford; 🇬🇧 Chew Magna, Bristol, United Kingdom

Chalmers Opticians; 🇬🇧 Cardiff, Glamorgan, United Kingdom

Harrold Opticians; 🇬🇧 Uxbridge, Middlesex, United Kingdom

Tempany's Boutique Opticians; 🇬🇧 Broadstone, Dorset, United Kingdom

Leightons; 🇬🇧 St Albans, Hertfordshire, United Kingdom

David Gould Opticians; 🇬🇧 Rawtenstall, Lancashire, United Kingdom

Boots Opticians Ltd; 🇬🇧 Birmingham, Warwickshire, United Kingdom