Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: comfilcon A; Device: lotrafilcon B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02815735

EX-MKTG-68 (VISA-407)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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85 participants in 2 patient groups

comfilcon A

Experimental group

Description:

Participants wear comfilcon A lens for 4 weeks during the cross over study.

Treatment:

Device: comfilcon A

lotrafilcon B

Active Comparator group

Description:

Participants wear lotrafilcon B lens for 4 weeks during the cross over study.

Treatment:

Device: lotrafilcon B