Phase 2 Conjunctival Allergen Challenge Trial of NTa53

JRCT ID: jRCT2031230051

Registered date:22/04/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Allergic Conjunctivitis
• Date of first enrollment: 20/06/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): NTa53 and placebo administration, and allergen challenge

Outcome(s)

• Primary Outcome: Efficacy (Subjective Ocular Symptom Score and Objective Findings Score), Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

-Japanese adult between the age of 18 to under 65 years at the time of the informed consent
-Specific IgE positive against cedar pollen allergens
-Other protocol-specified inclusion criteria may apply

Exclude criteria

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

Related Information

• Primary Sponsor: Hasunuma Tomoko