Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
NCT ID: NCT01055132
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2010-01-31
2010-02-28
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
SINGLE
Study Groups
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Nelfilcon A toric/ Etafilcon A toric
Nelfilcon A toric contact lens first, then etafilcon A toric toric second
Etafilcon A toric contact lens
contact lens to correct astigmatism
Nelfilcon A toric contact lens
contact lens to correct astigmatism
Etafilcon A toric contact lens/Nelfilcon A toric
Etafilcon A toric contact lens first, then nelfilcon A toric second
Etafilcon A toric contact lens
contact lens to correct astigmatism
Nelfilcon A toric contact lens
contact lens to correct astigmatism
Interventions
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Etafilcon A toric contact lens
contact lens to correct astigmatism
Nelfilcon A toric contact lens
contact lens to correct astigmatism
Eligibility Criteria
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Inclusion Criteria
* The subject must have normal eyes.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
* The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
* The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
* The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
* The subject must be an adapted wearer of soft toric contact lenses in both eyes.
* The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
* Subjects must already possess a wearable pair of spectacles.
Exclusion Criteria
* Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation
* Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Diabetes
* Strabismus
18 Years
40 Years
ALL
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Marietta, Georgia, United States
New York, New York, United States
Warwick, Rhode Island, United States
Countries
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Other Identifiers
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CR-1476AG
Identifier Type: -
Identifier Source: org_study_id
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