Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Study Overview
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Brief Summary
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The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.

Official Title
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Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Etafilcon A toric contact lens
* Device: Nelfilcon A toric contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be between 18 and 40 years old. The subject must have normal eyes. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye. The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye. The subject must be an adapted wearer of soft toric contact lenses in both eyes. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye. Subjects must already possess a wearable pair of spectacles. Exclusion Criteria: Ocular or systemic allergies or disease that may interfere with contact lens wear. Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Pregnancy or lactation Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). Diabetes Strabismus

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Etafilcon A toric contact lens/Nelfilcon A toric<br>Etafilcon A toric contact lens first, then nelfilcon A toric second | Device: Etafilcon A toric contact lens<br>* contact lens to correct astigmatism<br>Device: Nelfilcon A toric contact lens<br>* contact lens to correct astigmatism<br>|
| Other: Nelfilcon A toric/ Etafilcon A toric<br>Nelfilcon A toric contact lens first, then etafilcon A toric toric second | Device: Etafilcon A toric contact lens<br>* contact lens to correct astigmatism<br>Device: Nelfilcon A toric contact lens<br>* contact lens to correct astigmatism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Visual Acuity on LogMAR Scale | Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line. | After 5 to 9 days of lens wear | 
| Binocular Visual Acuity on LogMAR Scale | Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line. | After 5 to 9 days of lens wear | 
| Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire | The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD). | After 5 to 9 days of lens wear | 
| Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire. | The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD). | After 5 to 9 days of lens wear |