Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process

Study Overview
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Brief Summary
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This is a bilateral wear, dispensing, randomized, controlled, double-masked, 2-sequence × 2-period crossover study to evaluate ocular physiology following approximately one week of contact lens wear.

Official Title
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Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process

Conditions
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Ocular Physiology

Intervention / Treatment
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* Device: TEST LENS
* Device: CONTROL LENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must: Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Be between 18 and 39 (inclusive) years of age at the time of screening. By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week during the past month. Possess a wearable pair of spectacles that provide correction for distance vision. In both eyes, have astigmatic refractive error suitable for correction with the toric contact lens powers available in this study: Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps Cylinder powers (DC) -0.75 and -1.25 Axes (°) 170, 180, 10, 80, 90, 100 Have best corrected monocular distance visual acuity of 20/30 or better in each eye. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: The submit must not: Be currently pregnant or lactating. Be diabetic. Be currently using any ocular medications or have an ocular infection of any type. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. Be currently wearing monovision or multifocal contact lenses. Be currently wearing lenses in an extended wear modality. Have a history of strabismus or amblyopia. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEST/CONTROL<br>Eligible subjects that are habitual contact lens wearers will be randomized into the (test/control) sequence and wear two different study lens designs (test and control designs) one at a time bilaterally over 2 wear periods. | Device: TEST LENS<br>* AO1DfA manufactured with PG hydration<br>Device: CONTROL LENS<br>* AO1DfA manufactured with IPA hydration<br>|
| Experimental: CONTROL/TEST<br>Eligible subjects that are habitual contact lens wearers will be randomized into the (control/test) sequence and wear two different study lens designs (test and control designs) one at a time bilaterally over 2 wear periods. | Device: TEST LENS<br>* AO1DfA manufactured with PG hydration<br>Device: CONTROL LENS<br>* AO1DfA manufactured with IPA hydration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. | Up to 1-Week Follow-up |