Study Results
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View full resultsBasic Information
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COMPLETED
NA
371 participants
INTERVENTIONAL
2014-08-31
2014-11-30
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
NONE
Study Groups
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lotrafilcon B / etafilcon A
Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
lotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
etafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.
etafilcon A / lotrafilcon B
Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
lotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
etafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.
Interventions
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lotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
etafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Between 40 and 70 years of age.
4. Subjects must own a wearable pair of spectacles, if required for their distance vision.
5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration)
6. 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"\*
7. The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
8. Refractive cylinder ≤ -0.75 D in each eye.
9. ADD power in the range +0.75 D to +2.50 D in each eye.
10. Best corrected visual acuity of 20/20-3 or better in each eye.
Exclusion Criteria
2. Any ocular or systemic allergies that may have contraindicated contact lens wear.
3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
4. Any ocular abnormality that may have interfered with contact lens wear.
5. Use of any ocular medication, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
7. History of herpetic keratitis.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
10. History of diabetes.
11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
12. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
13. Any ocular infection or inflammation.
14. Any corneal distortion or irregular cornea.
40 Years
70 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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Montgomery, Alabama, United States
Mission Viejo, California, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Orange Park, Florida, United States
Saint Augustine, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Roswell, Georgia, United States
Pittsburg, Kansas, United States
East Lansing, Michigan, United States
Vestal, New York, United States
Denver, North Carolina, United States
Powell, Ohio, United States
Springfield, Ohio, United States
Warwick, Rhode Island, United States
Memphis, Tennessee, United States
Tyler, Texas, United States
Salem, Virginia, United States
Countries
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Other Identifiers
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CR-5593
Identifier Type: -
Identifier Source: org_study_id
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