臨床研究等提出・公開システム

Date of registration	Jan. 07, 2026
Last modified on	Jan. 07, 2026
Trial ID	jRCT2031250618

Scientific Title	ROH-201 ophthalmic solution phase II clinical trial in patients with vernal keratoconjunctivitis
Public Title	ROH-201 ophthalmic solution phase II clinical trial in patients with vernal keratoconjunctivitis

Contact for Scientific Queries	Name	Mantani Tomomi
	Affiliation	ROHTO Pharmaceutical Co., Ltd.
	Address	6-5-4, Kunimidai, Kizugawa, Kyoto 619-0216, Japan
	Telephone	+81-774-71-8802
	E-mail	rohtocl@rohto.co.jp
Contact for Public Queries	Name	Mantani Tomomi
	Affiliation	ROHTO Pharmaceutical Co., Ltd.
	Address	6-5-4, Kunimidai, Kizugawa, Kyoto 619-0216, Japan
	Telephone	+81-774-71-8802
	E-mail	rohtocl@rohto.co.jp

Recruitment status	Pending

Anticipated date of first enrollment		Jan. 07, 2026
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients for whom written informed consent was obtained from the subject or a legally authorized representative Patients with vernal keratoconjunctivitis 6 years and older at the time of informed consent
	Exclusion Criteria	Patients who require contact lens wear Patients who the principal/sub investigator has determined are not suitable to participate in this study
	Age Minimum	6age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Vernal keratoconjunctivitis
Intervention(s)		Administration of ROH-201 ophthalmic solution
Primary Outcome(s)		Change in clinical signs

Primary Sponsor	ROHTO Pharmaceutical Co., Ltd.

Name of Certified Review Board	IRB administrated by General incorporated associa tion of ethic committee for clinical trials
Address	2-12-13, Shinjuku, Shinjuku-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5050-4268
E-Mail	information@centriol-one.com

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none