Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses
NCT ID: NCT03139578
Last Updated: 2019-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2017-04-28
2017-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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C 8.5\C 9.0\T 8.5\T 9.0
Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
Test 8.5BC
senofilcon A contact lenses with 8.5 base curve
Test 9.0BC
senofilcon A contact lenses with 9.0 base curve
Control 8.5BC
narafilcon A contact lenses with 8.5 base curve
Control 9.0BC
narafilcon A contact lenses with 9.0 base curve
C 9.0\C 8.5\T 9.0\T 8.5
Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
Test 8.5BC
senofilcon A contact lenses with 8.5 base curve
Test 9.0BC
senofilcon A contact lenses with 9.0 base curve
Control 8.5BC
narafilcon A contact lenses with 8.5 base curve
Control 9.0BC
narafilcon A contact lenses with 9.0 base curve
T 8.5\T 9.0\C 8.5\C 9.0
Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
Test 8.5BC
senofilcon A contact lenses with 8.5 base curve
Test 9.0BC
senofilcon A contact lenses with 9.0 base curve
Control 8.5BC
narafilcon A contact lenses with 8.5 base curve
Control 9.0BC
narafilcon A contact lenses with 9.0 base curve
T 9.0\T 8.5\C 9.0\C 8.5
Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
Test 8.5BC
senofilcon A contact lenses with 8.5 base curve
Test 9.0BC
senofilcon A contact lenses with 9.0 base curve
Control 8.5BC
narafilcon A contact lenses with 8.5 base curve
Control 9.0BC
narafilcon A contact lenses with 9.0 base curve
Interventions
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Test 8.5BC
senofilcon A contact lenses with 8.5 base curve
Test 9.0BC
senofilcon A contact lenses with 9.0 base curve
Control 8.5BC
narafilcon A contact lenses with 8.5 base curve
Control 9.0BC
narafilcon A contact lenses with 9.0 base curve
Eligibility Criteria
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Inclusion Criteria
1. The subject must read and sign the Informed Consent form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Healthy adult males or females aged 18-55 years.
4. The subject's spherical contact lens requirement in the range +2.00 D to +4.00 D or -1.00 D to -6.00 D.
5. The subject's refractive cylinder must be ≤1.00 D in each eye.
6. The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye.
7. The subject is a current soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study).
8. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria
1. Currently pregnant or lactating
2. Any systemic disease (e.g., Sjögren's Syndrome),allergies, infectious disease (e.g., hepatitis,tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
4. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
5. Extended wear contact lens correction.
6. Any current use of ocular medication.
7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
8. Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale or any other ocular abnormality that may contraindicate contact lens wear.
9. Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear.
10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
11. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
18 Years
55 Years
ALL
Yes
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Aston University Optometry and Vision Science
Birmingham, , United Kingdom
Visioncare Research
Farnham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CR-5932
Identifier Type: -
Identifier Source: org_study_id
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