Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

Study Overview
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Brief Summary
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The objective of the study is to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

Detailed Description
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This study is a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

Official Title
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Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Lens A (comfilcon A toric lens)
* Device: Lens B (lehfilcon A toric lens)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer; Has read and signed an information consent letter; Self-reports having a full eye examination in the previous two years; Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears of toric soft contact lenses binocularly. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses; the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows: i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%)) iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%)) iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage) v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage) vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage) vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage) Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC; Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively; Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active ocular disease and/or infection that contraindicates contact lens wear; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens A, Then Lens B<br>Participants will wear Lens A for one month and then crossover to Lens B for one month. | Device: Lens A (comfilcon A toric lens)<br>* One month wear<br>Device: Lens B (lehfilcon A toric lens)<br>* One month wear<br>|
| Experimental: Lens B, Then Lens A<br>Participants will wear Lens B for one month and then crossover to Lens A for one month. | Device: Lens A (comfilcon A toric lens)<br>* One month wear<br>Device: Lens B (lehfilcon A toric lens)<br>* One month wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Handling on Removal | Lens Handling on Removal, using a 0-100 scale (0= Worst, 100=Best) | One month of wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity | Distance Visual Acuity, using Snellen converted to logMAR | One month wear |