Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light
Study Details
Study Description
Brief Summary
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort..
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: test/control/control Eligible subjects that are habitual contact lens wearers will be randomized into the (test/control/control) sequence and will wear two different study lenses one at a time bilaterally over three wear periods. |
Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore
TEST Lens
Device: ACUVUE OASYS 1-Day for Astigmatism
CONTROL Lens
|
| Experimental: control/test/test Eligible subjects that are habitual contact lens wearers will be randomized into the (control/test/test) sequence and will wear two different study lenses one at a time bilaterally over three wear periods. |
Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore
TEST Lens
Device: ACUVUE OASYS 1-Day for Astigmatism
CONTROL Lens
|
Outcome Measures
Primary Outcome Measures
- CLUE Comfort Score [at 1-week follow-up]
Subjective overall comfort will be assessed using Contact Lens User Experience (CLUE) questionnaire at the two-week follow-up. CLUE 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. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers
Eligibility Criteria
Criteria
Inclusion Criteria:
Potential subjects must satisfy of all 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 years of age (inclusive) at the time of screening.
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By self-report, habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
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Possess a wearable pair of spectacles that provide correction for distance vision.
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In both eyes, have 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 in 0.25 steps
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Cylinder powers (DC) -0.75 and -1.25
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Axes (degrees) 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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr. James Weber & Associates, PA - City Square Blvd | Jacksonville | Florida | United States | 32218 |
| 2 | Stam & Associates Eye Care | Jacksonville | Florida | United States | 32256 |
| 3 | Sabal Eye Care | Longwood | Florida | United States | 32779 |
| 4 | Maitland Vision Center - North Orlando Ave | Maitland | Florida | United States | 32751 |
| 5 | Southwest Orlando Eye Care | Orlando | Florida | United States | 32819 |
| 6 | Kannarr Eye Care | Pittsburg | Kansas | United States | 66762 |
| 7 | ProCare Vision Centers | Granville | Ohio | United States | 43023 |
| 8 | Dr. David W. Ferris & Associates | Warwick | Rhode Island | United States | 02888 |
| 9 | Optometry Group, LLC | Memphis | Tennessee | United States | 38111 |
| 10 | Tyler Eye Associates | Tyler | Texas | United States | 75703 |
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-6484