2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population
NCT ID: NCT02394808
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2015-01-01
2015-09-01
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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Test Lens 1
senofilcon A (Approved contact lens material)
senofilcon A
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
lotrafilcon B
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
Test Lens 2
lotrafilcon B (Approved contact lens material)
senofilcon A
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
lotrafilcon B
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
Interventions
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senofilcon A
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
lotrafilcon B
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
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. The subject must be 18 and less than 40 years of age.
4. The subject's corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00D in each eye with visual acuity of 20/25 provided study lenses in each eye.
5. The subject must have less than -1.00 D of cylindrical refraction.
6. The subject must have best corrected visual acuity of 20/25 or better in each eye.
7. The subject must be an adapted soft contact lens wearer in both eyes.
8. The subject must have normal eyes.
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. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned ocular or interocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
6. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer, or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
7. Any ocular infections
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment
10. History of binocular vision abnormality or strabismus.
11. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self report.
12. Employee of the investigational clinic (e.g. investigator, Coordinator, Technician)
18 Years
39 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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Chennai, Tamil Nadu, India
Countries
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Other Identifiers
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CR-5625
Identifier Type: -
Identifier Source: org_study_id
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