Phase 3 a long-term administration study of NTa53

JRCT ID: jRCT2031240352

Registered date:26/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Allergic Conjunctivitis
• Date of first enrollment: 16/09/2024
• Target sample size: 120
• Study type: Interventional
• Intervention(s): 56-day Administration of NTa53

Outcome(s)

Primary Outcome

Safety (Adverse Events, Ophthalmologic Examination and Clinical Examination)
Efficacy (Subjective Ocular Symptom Score, Objective Ocular Findings Score, Quality Of Life Survey)

Key inclusion & exclusion criteria

• Age minimum: >= 7age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Provided signed, written informed consent.
-Has a positive result from a Type I allergy test.

Exclude criteria

-Eye disease other than allergic conjunctivitis is present and requires treatment.
-Other protocol-specified exclusion criteria may apply.

Related Information

• Primary Sponsor: Yonemichi Takeshi