A0003 Eye Drops 0.55% Japan Phase III Study

JRCT ID: jRCT2021200029

Registered date:07/12/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Cystinosis
• Date of first enrollment: 01/12/2020
• Target sample size: 14
• Study type: Interventional
• Intervention(s): Administration of A0003 Eye Drops 0.55% 4 times day

Outcome(s)

• Primary Outcome: IVCM Total Score by in vivo confocal microscopy

Secondary Outcome

Luminance waveform analysis (LWA) by AS-OCT
Photophobia rated by investigators
Photophobia rated by patients

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Considered by the investigator or the sub-investigator being eligible for study participation, based on the results of screening tests conducted within 8 weeks before administration of A0003 Eye Drops 0.55%
Whose leukocyte cystine concentration measured before initiation of Cysteamine treatment was > 1 nmol/1/2 cystine/mg protein or who was diagnosed with cystinosis
Cystine crystal deposits in whose cornea was detected by slit lamp examination conducted at screening tests
Has ability to or intend to comply with the 4 times daily instillation regimen

Exclude criteria

Patients who have used Cysteamine eye drops within 1 year before administration of A0003 Eye Drops 0.55%
Patients with uncontrolled hepatic disorder, cardiovascular disease, neurologic disease, or a cancer complication
Patients with a history of hypersensitivity to Cysteamine, benzalkonium chloride, disodium edetate, carmellose sodium, citric acid monohydrate, or penicillamine

Related Information

• Primary Sponsor: Ito Shuichi