Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear
NCT ID: NCT01765972
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2012-12-31
2013-05-31
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
DOUBLE
Study Groups
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Test 1/Spectacles/Test 2/Test 3
Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 1 (etafilcon A with Lacreon), spectacles, TEST 2 (etafilcon A with Lacreon with print) and TEST 3 (etafilcon A with print) in both eyes for 8 +/-1 hours.
etafilcon A with Lacreon
contact lens with Lacreon
etafilcon A with Lacreon with print
contact lens with Lacreon and cosmetic print
etafilcon A with print
contact lens with print
Spectacles (habitual)
Spectacles
Test 2/Test 3/ Spectacles/Test 1
Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 2 (etafilcon A with Lacreon with print), TEST 3 (etafilcon A with print), spectacles and TEST 1 (etafilcon A with Lacreon) in both eyes for 8 +/-1 hours.
etafilcon A with Lacreon
contact lens with Lacreon
etafilcon A with Lacreon with print
contact lens with Lacreon and cosmetic print
etafilcon A with print
contact lens with print
Spectacles (habitual)
Spectacles
Test 3/Test 1/ Test 2/ Spectacles
Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 3 (etafilcon A with print), TEST 1 (etafilcon A with Lacreon), TEST 2 (etafilcon A with Lacreon with print) and spectacles in both eyes for 8 +/-1 hours.
etafilcon A with Lacreon
contact lens with Lacreon
etafilcon A with Lacreon with print
contact lens with Lacreon and cosmetic print
etafilcon A with print
contact lens with print
Spectacles (habitual)
Spectacles
Spectacles/Test 2/Test 1/Test 3
Subjects assigned randomly to this arm will wear the study lenses sequentially as spectacles, TEST 2 (etafilcon A with Lacreon with print), TEST 1 (etafilcon A with Lacreon) and TEST 3 (etafilcon A with print) in both eyes for 8 +/-1 hours.
etafilcon A with Lacreon
contact lens with Lacreon
etafilcon A with Lacreon with print
contact lens with Lacreon and cosmetic print
etafilcon A with print
contact lens with print
Spectacles (habitual)
Spectacles
Interventions
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etafilcon A with Lacreon
contact lens with Lacreon
etafilcon A with Lacreon with print
contact lens with Lacreon and cosmetic print
etafilcon A with print
contact lens with print
Spectacles (habitual)
Spectacles
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 the clinical protocol.
3. The subject must be between 18 and 45 years of age.
4. The subject must be an adapted soft contact lens wearer in both eyes.
5. The subject must be of East or Southeast Asian descent, e.g. ethnic Chinese, Japanese, Korean, Malay, Vietnamese, Indonesian, Filipino, etc. (it is preferred but not required that both the subject's biological parents are East or Southeast Asian ethnicity, by self report).
6. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D in each eye.
7. The subject's refractive cylinder must be no more than 1.00D in each eye.
8. The subject must have best corrected visual acuity of +0.14 logMAR (equivalent to 20/25-2) or better in each eye.
9. Subjects must own a wearable pair of spectacles and wear them on the day of the initial visit, during the washout before each phase and during the no lens wear phase.
10. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria
2. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but may not be limited to, diabetes. hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, HIV/AIDS, hepatitis, and tuberculosis.
4. Use of any topical medications such aas eye drops or ointments.
5. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion, or aphakia.
6. Had any previous, or planned ocular or intraocular surgery (e.g. cataract surgery, radial keratotomy, PRK, LASIK, etc.).
7. Have any grade 2.0 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron classification scale or any other ocular abnormality that may contraindicate contact lens wear.
8. Have any known hypersensitivity or allergic reaction to one of the study products.
9. Have any ocular infection.
10. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
11. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
12. Have any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV by self report).
13. Currently wear their contact lenses on an extended wear basis.
14. Are an employee of the investigational clinic (e.g. Investigator, Coordinator, Technician)
18 Years
45 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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Waterloo, Ontario, Canada
Countries
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Other Identifiers
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CR-5252
Identifier Type: -
Identifier Source: org_study_id
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