A study to develop a novel ophthalmic testing method in patients with cystinosis

JRCT ID: jRCTs031220490

Registered date:05/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cystinosis
• Date of first enrollment: 05/12/2022
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Administration of A0003 Eye Drops 0.55% 4 times day for 52 weeks

Outcome(s)

• Primary Outcome: Luminance waveform analysis (LWA) by using AS-OCT

Secondary Outcome

Photophobia rated by investigators
Photophobia rated by patients

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with cystinosis who meet the following criteria
1) Patients with presence of corneal cystine crystal deposits assessed during ophthalmic examination
2) Patients who have ability to or intend to comply with the 4 times daily instillation regimen
3) Patients who are judged by the principal investigator or sub-investigator to be appropriate for inclusion in the study.
4) Patients who have given written consent to participate in the research in person.
5) Patients who are at least 18 years of age at the time consent is obtained

Exclude criteria

1) Patients who are obviously suffering from a serious acute disease
2) Patients with a history of hypersensitivity to the active ingredients or additives of the test drug
3) Pregnant or possibly pregnant or lactating women
4) Persons who are judged by the principal investigator to be inappropriate for inclusion in the study

Related Information

• Primary Sponsor: Yamamoto Yuuka
• Source(s) of Monetary Support: Grants-in-Aid for Research from the National Center for Global Health and Medicine