Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

Study Overview
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Brief Summary
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The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.

Detailed Description
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The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.

Official Title
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Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Fanfilcon A toric lens
* Device: Lotrafilcon B toric lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is between 18 and 40 years of age (inclusive) Has had a self-reported visual exam in the last two years Is an adapted soft contact lens wearer Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive) Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes. Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter. Patient contact lens refraction should fit within the available parameters of the study lenses. Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so). Is willing to comply with the visit schedule Exclusion Criteria: A person will be excluded from the study if he/she: Has a CL prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. Presence of clinically significant (grade 2-4) anterior segment abnormalities Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has Presbyopia or has dependence on spectacles for near work over the contact lenses. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: fanfilcon A toric<br>Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study. | Device: Fanfilcon A toric lens<br>* Contact lens<br>* Other names: Avaira Vitality toric lens;|
| Active Comparator: lotrafilcon B<br>Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study. | Device: Lotrafilcon B toric lens<br>* Contact lens<br>* Other names: AIR OPTIX for Astigmatism;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Centration | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) | Baseline | 
| Lens Centration | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) | Dispense | 
| Lens Centration | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) | 1 Month | 
| Corneal Coverage | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) | Baseline | 
| Corneal Coverage | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) | Dispense | 
| Corneal Coverage | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) | 1 Month | 
| Post-blink Movement | Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) | Baseline | 
| Post-blink Movement | Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) | Dispense | 
| Post-blink Movement | Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) | 1 Month | 
| Overall Fit Acceptance | Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect) | Dispense | 
| Overall Fit Acceptance | Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect) | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Hours of Wear Per Day | Number of hours lenses are worn per day | Baseline | 
| Average Hours of Wear Per Day | Number of hours lenses are worn per day | 1 month | 
| Average Comfortable Wearing Time | Typical time of day when subject first experiences lens awareness or irritation. | Baseline | 
| Average Comfortable Wearing Time | Typical time of day when subject first experiences lens awareness or irritation | 1 Month |