Clinical evaluation of two types of daily disposable silicone hydrogel contact lenses in habitual CL wearers.

JRCT ID: jRCTs032210342

Registered date:24/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: myopic astigmatism
• Date of first enrollment: 01/05/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Randomly select the first SCL and use it for 2 weeks, then switch to the other SCL.

Outcome(s)

Primary Outcome

Total score of DEQ 5 (questionnaire regarding wearing).
Two groups, the new SCL Precision One and the existing SCL One Day Acuvue True Eye, will be compared.

Secondary Outcome

Total score of J-CLDEQ-8 (questionnaire on the comfort of wearing CL)
Two groups, the new SCL Precision One and the existing SCL One Day Acuvue True Eye, will be compared.

Key inclusion & exclusion criteria

• Age minimum: >= 13age old
• Age maximum: <= 40age old
• Gender: Both

Include criteria

1.The consent in writing has obtained. In the case of a minor patient, the consent of the representative in addition to the patient should be obtained
2.Aged 13 to 40 years old must sign the informed consent
3.Habitual soft silicone hydrogel contact lenses wearers
4.Requiring lenses within the power range of both study contact lenses to be fitted (-0.50D to -6.00D)
5.Vision correctable 0.8 (20/25) or better in each eye at distance with pre-study contact lenses at Baseline
6.daily disposable silicone hydrogel contact lenses in habitual CL wearers
7.Have subjective symptoms of dry eye as defined by the Symptomatology eligibility questionnaires

Exclude criteria

1.Subjects with systemic disease
2.Use of systemic or local antibiotics or corticosteroids
3.Use of immunomodulatory
4.pregnancy or breastfeeding
5.History of eye surgery trauma within 6 months of the enrollment visit
6.Current wearing DT1 or 1-Day Acuvue TruEye sphere lenses
7.Subjects who have no appropriate judgement
8.Those who work for a company that manufactures and sells contact lenses
9.Patient who in judged ineligible as patients in this clinical study by the investigator

Related Information

• Primary Sponsor: Mimura Tatsuya
• Source(s) of Monetary Support: Alcon Japan Ltd