Tokyo, May 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061452) titled 'Clinical Evaluation of Disposable Silicone Hydrogel Contact Lenses' on May 4.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tsurumi University School of Dentistry
Condition:
Condition - myopia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the comfort of disposable silicone hydrogel contact lenses among current contact lens wearers.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Wearing contact lenses
Eligibility:
Age-lower limit - 13
years-old
Gender - Male and Female
Key inclusion criteria - 1.Aged 13 to 60 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.
Key exclusion criteria - Subjects with systemic diseases will be excluded. Subjects with a history of ophthalmic surgery or trauma within 6 months of study enrollment, or who have used topical or systemic antibiotics or corticosteroids, immunomodulators, or who are pregnant or breastfeeding, will also be excluded.
Target Size - 60
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 07 Month 01 Day
Date of IRB - 2022 Year 03 Month 31 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070317
Disclaimer: Curated by HT Syndication.
