Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology to Evaluate Overall Visual Acuity.
Study Details
Study Description
Brief Summary
This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TEST Lens Eligible subjects who are habitual soft contact lens wearers will be randomized into the TEST Lens for the duration of the study. |
Device: senofilcon A contact lenses made with a novel manufacturing technology
TEST Lens
|
| Experimental: CONTROL Lens Eligible subjects who are habitual soft contact lens wearers will be randomized into the CONTROL Lens for the duration of the study. |
Device: senofilcon A contact lenses made with the current manufacturing technology
CONTROL Lens
|
Outcome Measures
Primary Outcome Measures
- Average daily wear time (in hours) [up to 2-week follow-up]
Average daily wear time will be calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 2-Week follow-up evaluation.
- LogMAR distance Visual Acuity (HLLC) [up to 2-week follow-up]
Visual performance will be calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This will be evaluated under high luminance(120 - 200 cd/m2)/low contrast (<2.5 lux) conditions at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
- LogMAR distance Visual Acuity (LLHC) [up to 2-week follow-up]
Visual performance will be calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This will be evaluated under low luminance (2.0 - 5.0 cd/m2)/high contrast (>400 lux) conditions at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Secondary Outcome Measures
- CLUE Comfort Score [up to 2-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.
- CLUE Vision Score [up to 2-week follow-up]
Subjective overall vision 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 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 spherical soft silicone hydrogel 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 5 days per week during the past 30 days.
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Possess a wearable pair of spectacles that provide correction for distance vision.
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The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye.
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The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (inclusive) in each eye.
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The best corrected, monocular, distance visual acuity must be 20/25 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 currently using any ocular medications or have any 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 the investigator believes 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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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 participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
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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 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 the investigator believes will 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). (Specify method of determination if needed).
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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 | Flora Chen Poveda OD, PA - Orange Park | Orange Park | Florida | United States | 32073 |
| 3 | Tallahassee Eye Center | Tallahassee | Florida | United States | 32308 |
| 4 | Sacco Eye Group | Vestal | New York | United States | 13850 |
| 5 | William J. Bogus, O.D. | Salt Lake City | Utah | United States | 84106 |
| 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-6474