Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: comfilcon A
* Device: lotrafilcon B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: comfilcon A<br>Participants wear comfilcon A lens for 4 weeks during the cross over study. | Device: comfilcon A<br>* contact lens<br>|
| Active Comparator: lotrafilcon B<br>Participants wear lotrafilcon B lens for 4 weeks during the cross over study. | Device: lotrafilcon B<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | 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. | Baseline, 2 weeks, 4 weeks | 
| Comfort During the Day | 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. | Days 3, 12, 26 |