Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

Study Overview
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Brief Summary
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Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Detailed Description
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CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.

Official Title
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Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

Conditions
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Astigmatism

Intervention / Treatment
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* Device: stenfilcon A toric lens
* Device: etafilcon A toric lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is an adapted soft contact lens wearer; Requires a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes); Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week; Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye; To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable. Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection; 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 a study outcome variable; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating (by verbal confirmation at the screening visit); Is aphakic; Has undergone refractive error surgery

Ages Eligible for Study
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Minimum Age: 17 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stenfilcon A toric lens<br>Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. | Device: stenfilcon A toric lens<br>* toric contact lens<br>|
| Active Comparator: etafilcon A toric lens<br>Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. | Device: etafilcon A toric lens<br>* toric contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt. | Baseline and 1 Week | 
| Handling | Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle. | Baseline and 1 Week | 
| Vision | Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent. | Baseline and 1 Week | 
| High Visual Acuity | High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR. | Baseline and 1 Week | 
| Low Visual Acuity | Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR. | Baseline and 1 Week | 
| Lens Surface - Wettability | Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability. | Baseline and 1 Week | 
| Lens Surface - Deposits | Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits. | Baseline and 1 Week | 
| Corneal Staining, Type | Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior | Baseline and 1 week | 
| Corneal Staining, Extent | Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior | Baseline and 1 week | 
| Conjunctival Staining | Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent N - Nasal, T - Temporal, S - Superior, I - Inferior | Baseline and 1 week | 
| Lens Durability | Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study). | 1 Week | 
| Lens Fit Acceptance | Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum. | Baseline and 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dryness | Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time. | 1 Week | 
| Overall Satisfaction | Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied. | Baseline and 1 week |