Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TEST/CONTROL 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
AO1DfA manufactured with PG hydration
Device: CONTROL LENS
AO1DfA manufactured with IPA hydration
|
| Experimental: CONTROL/TEST 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
AO1DfA manufactured with PG hydration
Device: CONTROL LENS
AO1DfA manufactured with IPA hydration
|
Outcome Measures
Primary Outcome Measures
- Biomicroscopy [at 1-week follow-up]
Biomicroscopy (slit lamp findings) will be assessed following a 7(±2) day wear period. FDA Slit Lamp Classification Scale will be used to grade the findings. The percentage of eyes with clinically significant slit lamp findings (i.e., Grade 3 or higher, or significant corneal infiltrates) will be analyzed.
Eligibility Criteria
Criteria
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
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Appear able and willing to adhere to the instructions set forth in this clinical protocol.
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Be between 18 and 39 (inclusive) years of age at the time of screening.
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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.
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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:
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Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps
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Cylinder powers (DC) -0.75 and -1.25
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Axes (°) 170, 180, 10, 80, 90, 100
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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:
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Be currently pregnant or lactating.
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Be diabetic.
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Be currently using any ocular medications or have an ocular infection of any type.
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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.
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Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
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Be currently wearing monovision or multifocal contact lenses.
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Be currently wearing lenses in an extended wear modality.
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Have a history of strabismus or amblyopia.
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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.
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Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
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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).
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Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
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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.).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VRC | Jacksonville | Florida | United States | 32256 |
| 2 | Maitland Vision Center - North Orlando Ave | Maitland | Florida | United States | 32751 |
| 3 | Sacco Eye Group | Vestal | New York | United States | 13850 |
| 4 | Optometry Group, LLC | Memphis | Tennessee | United States | 38111 |
| 5 | Tyler Eye Associates | Tyler | Texas | United States | 75703 |
| 6 | Botetourt Eyecare, LLC | Salem | Virginia | United States | 24153 |
Sponsors and Collaborators
- Johnson & Johnson Vision Care, Inc.
Investigators
- Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR-6482