Clinical Evaluation of Investigational Multifocal Contact Lenses
NCT ID: NCT03059810
Last Updated: 2019-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2017-01-27
2017-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participating Subjects
Participating Subjects who are habitual soft contact lens wearers, aged 40 to 70 years of age, will be dispensed investigational contact lenses to be worn from 12-16 days, to include a total of 3 visits.
etafilcon A
Investigational Contact Lens
Interventions
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etafilcon A
Investigational Contact Lens
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. Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
4. The subject must either 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".(Appendix B).
5. The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
6. The subject's refractive spherical component must be between +1.25 Diopters (D) to +3.75 D in each eye.
7. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye.
8. The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
10. The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.
11. The subject must have a wearable pair of spectacles if required for their distance vision.
Exclusion Criteria
2. Pregnancy or lactation.
3. Currently diagnosed with diabetes.
4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
5. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
7. Any previous, or planned, ocular or intraocular surgery (e.g.radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), lid procedures, cataract surgery, retinal surgery, etc.).
8. A history of amblyopia, strabismus or binocular vision abnormality.
9. Any ocular infection or inflammation.
10. Any ocular abnormality that may interfere with contact lens wear.
11. Use of any ocular medication, with the exception of rewetting drops.
12. History of herpetic keratitis.
13. Participation in any contact lens or lens care product clinical trial within 30 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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EYE Center Optometric
Rocklin, California, United States
Dr. Ted Brink & Associates
Jacksonville, Florida, United States
Vistakon Research Clinic
Jacksonville, Florida, United States
Golden Vision
Sarasota, Florida, United States
Eye Associates of Winter Park
Winter Park, Florida, United States
University of Indiana School of Optometry
Bloomington, Indiana, United States
Sacco Eye Group
Vestal, New York, United States
Optometry Group, PLLC
Memphis, Tennessee, United States
Total Eye Care, PA
Memphis, Tennessee, United States
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-5903
Identifier Type: -
Identifier Source: org_study_id