Safety and Effectiveness of the Qualis Contact Lens

Study Overview
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Brief Summary
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Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study.

Detailed Description
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Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study comparing the Qualis Silicone Hydrogel Soft Contact Lens for Daily Wear with the currently marketed Acuvue Vita (senofilcon C) Monthly Contact Lens (FDA cleared under K160212). Eligible subjects will be examined for baseline evaluation and lens fitting. Up to fifty (50) subjects will wear the test contact lenses and up to twenty-five (25) subjects will wear the control contact lenses. The subjects will undergo standard ophthalmic evaluation for contact lens wear and will be followed for a period of at least ninety (91) days.

Official Title
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Clinical Performance of Qualis Silicone Hydrogel Soft Contact Lens Over 3 Months of Daily Wear

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: soft (hydrophilic) contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must read, understand, and sign the informed consent form and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be at least 18 years of age. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye. The subject's refractive cylinder must be ≤ 0.75 Diopters in each eye. The subject must have best corrected visual acuity of 20/25 (LogMAR) or better in each eye. Subjects should own a wearable pair of spectacles. The subject must have normal eyes (i.e., no ocular medications or infections of any type). Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week Exclusion Criteria: Subjects may not be enrolled into the study if ANY of the following apply: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). The use of systemic or ocular medications that would contraindicate contact lens wear. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.). Any grade 2 or greater slit lamp findings for corneal staining, and any grade 3 or greater slit lamp findings for other abnormalities (e.g., edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) on the ISO 11980 classification scale, any current inflammatory events or events within the last 6 months, or any other ocular abnormality that may contraindicate contact lens wear. Any known hypersensitivity or allergic reaction to Biotrue or ClearCare contact lens care solutions Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Extended wear, monovision or multi-focal contact lens correction. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. Any subject where the randomized lens demonstrates a fit that is deemed inappropriate by the investigator, including, but not limited to, the lens being too flat, too steep, have excessive or inadequate movement, and/or insufficient limbal coverage. Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician)

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Device: Qualis Silicone Hydrogel Soft Contact Lens<br>Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. | Device: soft (hydrophilic) contact lens<br>* The intervention is a daily wear soft contact lens<br>|
| Active Comparator: Control Device: Acuvue Vita Monthly Contact Lens<br>Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. | Device: soft (hydrophilic) contact lens<br>* The intervention is a daily wear soft contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Non-Serious Adverse Reactions | The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations. | 91 days | 
| Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better | The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of +0.10 logMAR or better | 91 days |