Evaluation of stability of lacrimal fluid under environmental stimulation when using of soft contact lenses

JRCT ID: jRCTs032230103

Registered date:29/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy
• Date of first enrollment: 13/10/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Subjects will wear contact lenses(PRECISION 1TM or 1-DAY ACUVUE TruEye) in both eyes and visit to the hospital after at least 7 hours have passed.At each visit,current of air sent by an electric fan as an environmental stimulus will be applied to the subject's face from 3meters with an intensity of 3m/s for 10minutes,and an objective and subjective examinations will be performed on the right eye.

Outcome(s)

• Primary Outcome: Non-invasive tear film breakup time when wearing study contact lenses
• Secondary Outcome: Ocular surface blood flow value, ocular surface temperature value, and subjective symptoms after environmental stimulation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

1.Subjects who are over the age of 20 and under 40 years old, and capable of giving written informed consent
2.Subjects who are using of the contact lens within suppliable range of power
3.Subjects who wear daily disposable SCL for at least 6hours a day and more than 5days a week
4.Subjects who have not used CL(contact lenses) for 2 days after washout (wearing glasses,etc.)

Exclude criteria

1.Regular users of PRECISION 1TM or 1-DAY ACUVUE TruEye
2.Subjects who have obvious worsening of subjective symptoms immediately after wearing the research lens (1)and(2)to be compared, or who have poor fitting of the research lens
3.Subjects with a history of ophthalmic surgery
4.Subjects who have been diagnosed with dry eye by a doctor,who are prescribed dry eye drops,or who are using over-the-counter eye drops.
5.Subjects who are judged inappropriate for participation of the study by the investigator

Related Information

• Primary Sponsor: Hori Yuichi
• Source(s) of Monetary Support: Alcon Japan Ltd