Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population
NCT ID: NCT01763047
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
298 participants
INTERVENTIONAL
2012-11-30
2013-02-28
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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etafilcon A/lotrafilcon B
Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the etafilcon A lens and then wore the lotrafilcon B lens.
etafilcon A
To be worn in a daily wear modality for a minimum of 6 hours per day.
lotrafilcon B
Lenses will be worn in a reuseable modality; cleaned and disinfected each night.
lotrafilcon B/etafilcon A
Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the lotrafilcon B lens and then wore the etafilcon A lens.
etafilcon A
To be worn in a daily wear modality for a minimum of 6 hours per day.
lotrafilcon B
Lenses will be worn in a reuseable modality; cleaned and disinfected each night.
Interventions
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etafilcon A
To be worn in a daily wear modality for a minimum of 6 hours per day.
lotrafilcon B
Lenses will be worn in a reuseable modality; cleaned and disinfected each night.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
3. Subjects must be between 40 and 70 years of age.
4. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
5. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.
6. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.
7. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.
8. Subjects' should own a wearable pair of spectacles.
9. Subjects' must 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 or more duration).
10. Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).
Exclusion Criteria
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
5. 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.
6. Any ocular infection.
7. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
10. History of diabetes.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
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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Mission Viejo, California, United States
RPS
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Saint Augustine, Florida, United States
Tallahassee, Florida, United States
Winter Park, Florida, United States
Roswell, Georgia, United States
Lutherville, Maryland, United States
Closter, New Jersey, United States
New York, New York, United States
Denver, North Carolina, United States
Athens, Ohio, United States
Kingston, Pennsylvania, United States
Warwick, Rhode Island, United States
Memphis, Tennessee, United States
Amarillo, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Salem, Virginia, United States
Countries
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Other Identifiers
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CR-5357
Identifier Type: -
Identifier Source: org_study_id
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