ROH-201 ophthalmic solution Phase 2a clinical trial

JRCT ID: jRCT2051200158

Registered date:18/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dry eye disease
• Date of first enrollment: 11/03/2021
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Administer ROH-201 ophthalmic solution or placebo to participants with dry eye disease

Outcome(s)

• Primary Outcome: Change from baseline in fluorescein 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: Kitano Takashi