Influence of therapeutic agent for glaucoma on biological clock

JRCT ID: jRCTs071180026

Registered date:28/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy
• Date of first enrollment: 29/03/2019
• Target sample size: 16
• Study type: Interventional

Intervention(s)

A part: Instillation of Xalatan Eye Drops 0.005% or placebo to both eye (1 drop/eye, 1 drop/day, 17:00)
B part: Swabbing of Xalatan Eye Drops 0.005% or placebo on jaw (3 cm*3 cm) by cotton (1 drop/jaw, 1 drop/ day, 09:00)

Outcome(s)

Primary Outcome

1. Cortisol concentration in saliva
2. Clock gene expression level in hair follicle
3. Electroretinogram

• Secondary Outcome: Adverse events, vital sign

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 35age old
• Gender: Male

Include criteria

1. Written informed consent
2. No shift work, no overseas travel during the study
3. Detection of cortisol in saliva

Exclude criteria

1. Steroid administration
2. Overseas travel before the study
3. Sleeping pill administration
4. Delayed sleep phase syndrome

Related Information

• Primary Sponsor: Yoshihara Tatsuya
• Secondary Sponsor: Pharmaceutical Sciences Kyusyu University