Unique ID issued by UMIN | UMIN000042269 |
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Receipt number | R000048255 |
Scientific Title | Study title Clinical evaluation of two types of daily disposable silicone hydrogel contact lenses in habitual CL wearers. |
Date of disclosure of the study information | 2020/10/28 |
Last modified on | 2020/10/28 15:11:51 |
Clinical evaluation of two types of daily disposable silicone hydrogel contact lenses in habitual CL wearers.
Clinical evaluation of silicone hydrogel contact lenses.
Study title Clinical evaluation of two types of daily disposable silicone hydrogel contact lenses in habitual CL wearers.
Clinical evaluation of silicone hydrogel contact lenses.
Japan |
myopia
Ophthalmology |
Others
NO
Objects To investigate the subjective comfort and lens fit characteristics of Precision 1 compared to 1-Day Acuvue TruEye in a Japanese CL habitual wearers.
Efficacy
1)Corrected visual acuity
2)Lens centration/ fit
3)BUT
4)Subjective questionnaires (comfort, vision, handling, dry eye symptoms)
Interventional
Cross-over
Randomized
Cluster
Double blind -all involved are blinded
Active
2
Treatment
Device,equipment |
Wearing contact lenses
Switching between two types of contact lenses
13 | years-old | <= |
40 | years-old | >= |
Male and Female
1.Aged 13 to 40 years old must sign the informed consent.
2.Habitual soft/ silicone hydrogel contact lenses wearers.
3.Requiring lenses within the power range of both study contact lenses to be fitted (-0.50D to -6.00D).
4.Vision correctable 0.8 (20/25) or better in each eye at distance with pre-study contact lenses at Baseline.
5.Have subjective symptoms of contact lens discomfort as defined by the Symptomatology eligibility questionnaires.
1.Current wearing DT1 or 1-Day Acuvue TruEye sphere lenses.
2.Subjects with systemic disease.
3.History of eye surgery/ trauma, use of systemic or local antibiotics or corticosteroids, use of immunomodulatory, pregnancy or breastfeeding within 6 months of the enrollment visit
4.Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
5.Participation in any clinical trial within 30 days of the enrollment visit.
6.Patient who in judged ineligible as patients in this clinical study by the investigator.
60
1st name | Tatsuya |
Middle name | |
Last name | Mimura |
Teikyo University
School of Medicine, Department of Ophthalmology
173-8605
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
03-3964-1211
mimurat@med.teikyo-u.ac.jp
1st name | Tatsuya |
Middle name | |
Last name | Mimura |
Teikyo University
School of Medicine, Department of Ophthalmology
173-8605
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
03-3964-1211
mimurat@med.teikyo-u.ac.jp
Teikyo University
Teikyo University
Self funding
Nerima West Eye Clinic
Alcon Japan Ltd
Teikyo University
2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
03-3964-1211
mimurat@med.teikyo-u.ac.jp
NO
2020 | Year | 10 | Month | 28 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 10 | Month | 26 | Day |
2020 | Year | 10 | Month | 13 | Day |
2020 | Year | 11 | Month | 01 | Day |
2023 | Year | 03 | Month | 31 | Day |
2020 | Year | 10 | Month | 28 | Day |
2020 | Year | 10 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048255
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