Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product
Study Details
Study Description
Brief Summary
This is a single-masked, two-arm, parallel-group, randomized-controlled, dispensing clinical trial to evaluate the visual performance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: TEST Lens Eligible subjects who are habitual soft contact lens wearers will be randomized to the TEST Lens sequence for the duration of the study. |
Device: senofilcon A C3
TEST Lens
|
| Experimental: CONTROL Lens Eligible subjects who are habitual soft contact lens wearers will be randomized to the CONTROL Lens sequence for the duration of the study. |
Device: Dailies Total 1 Multifocal Contact Lenses
CONTROL Lens
|
Outcome Measures
Primary Outcome Measures
- Distance LogMAR Visual Acuity [at 1-week follow-up]
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale will be evaluated at distance (4 meters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance is required to be between 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 9.9-10.6 EV (120-200 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
- Intermediate LogMAR Visual Acuity [at 1-week follow-up]
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale will be evaluated at intermediate (64 centimeters) under high luminance high contrast lighting condition using reduced Guillon-Poling charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For Intermediate (64 cm), the acceptable range for the chart luminance 10.8-11.1 EV (225-275 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
- Near Visual Acuity [at 1-week follow-up]
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at near (40 centimeters) under high luminance high contrast lighting condition u using reduced Guillon-Poling charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (225-275 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
- CLUE Vision Score [at 1-week follow-up]
Subjective quality of vision will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 2-weeks of wear. 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 with a range of 0-120. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens wearers
Eligibility Criteria
Criteria
Inclusion Criteria:
- Potential subjects must satisfy all the following criteria to be enrolled in the study:
-
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 at least 40 years of age and not greater than 70 years of age at the time of consent.
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Own a wearable pair of spectacles if required for their distance vision.
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Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).
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Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
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The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D or +1.25 D to +3.75 D in each eye.
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The subject's refractive cylinder must be ≤0.75 D in each eye.
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The subject's ADD power must be in the range of +0.75 D to +2.50 D.
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The subject must have distance best corrected visual acuity of 20/20-3 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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Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
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Have any active or ongoing 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, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
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Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
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Have a history of amblyopia, strabismus or binocular vision abnormality.
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Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See Table 9.1 for further examples.
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Use of any ocular medication, with the exception of rewetting drops.
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Have a history of herpetic keratitis.
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Have a history of irregular cornea.
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Have a history of pathological dry eye.
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Have Participated in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
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Be and employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
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Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
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Have clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
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Have any current ocular infection or inflammation.
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Have any current ocular abnormality that may interfere with contact lens wear.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stam & Associates Eye Care | Jacksonville | Florida | United States | 32256 |
| 2 | Sabal Eye Care | Longwood | Florida | United States | 32779 |
| 3 | Visual Eyes | Roswell | Georgia | United States | 30076 |
| 4 | Kannarr Eye Care | Pittsburg | Kansas | United States | 66762 |
| 5 | Birmingham Vision Care | Bloomfield Township | Michigan | United States | 48301 |
| 6 | Eye Associates of New York | New York | New York | United States | 10022 |
| 7 | ProCare Vision Centers | Granville | Ohio | United States | 43023 |
| 8 | West Bay Eye Associates | Warwick | Rhode Island | United States | 028888 |
| 9 | 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-6468