ROH-201 ophthalmic solution phase IIb clinical trial

JRCT ID: jRCT2031220368

Registered date:07/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Dry eye disease
• Date of first enrollment: 25/10/2022
• Target sample size: 300
• Study type: Interventional
• Intervention(s): Administration of ROH-201 ophthalmic or placebo to patients with dry eye

Outcome(s)

• Primary Outcome: Amount of change from baseline in staining score

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Tear film break-up time of <= 5 seconds
- Have a subjective symptoms of Dry Eye Disease
- 20 years and older at the time of Informed Consent

• Exclude criteria: - Contact lens wearers who cannot discontinue the wear over the trial period

Related Information

• Primary Sponsor: Mantani Tomomi