Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses

Study Overview
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Brief Summary
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Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses

Detailed Description
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Prospective, double-masked (investigator and participant), bilateral, randomized, cross-over dispensing study comparing the MyDay Toric (test) against the 1-day Acuvue Moist for Astigmatism (control), and Dailies Aquacomfort Plus Toric (control) lenses

Official Title
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Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Dailies Aquacomfort Plus Toric
* Device: 1-Day Acuvue Moist for Astigmatism
* Device: MyDay Toric


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Has had a self-reported oculo-visual examination in the last two years. 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; Is willing to wear contact lens in both eyes for the duration of the study; Has a minimum spectacle astigmatism of - 0.75; Can be fit with the three study contact lens types in the powers available; Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best corrected vision (for binocular distance acuity); 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; For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Exclusion Criteria: Is participating in any concurrent clinical trial; 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 fluorescein dye or products to be used in the study; Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses; Is pregnant, lactating or planning a pregnancy at the time of enrolment (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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyDay Toric<br>Participants were randomized to wear a new pair of MyDay Toric lenses each day for one week during the cross over study | Device: MyDay Toric<br>* daily disposable contact lens<br>* Other names: MDT;|
| Active Comparator: 1-Day Acuvue Moist for Astigmatism<br>Participants were randomized to wear a new pair of 1-Day Acuvue Moist Toric lenses each day for one week during the cross over study | Device: 1-Day Acuvue Moist for Astigmatism<br>* daily disposable contact lens<br>* Other names: 1-Day AM;|
| Active Comparator: Dailies Aquacomfort Plus Toric<br>Participants were randomized to wear a new pair of Dailies Aquacomfort Plus Toric lenses each day for one week during the cross over study | Device: Dailies Aquacomfort Plus Toric<br>* daily disposable contact lens<br>* Other names: DACP;|

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. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses. | 1 week | 
| Dryness | Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness | 1 week | 
| Visual Quality | Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied | 1 week | 
| Lens Preference With Respect to Overall Comfort | Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference | 1 week | 
| Lens Preference With Respect to Visual Quality | Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference | 1 week |