A0003 Eye Drops 0.55% Japan Phase III Study
- Conditions
- Cystinosis
- Registration Number
- JPRN-jRCT2021200029
- Lead Sponsor
- Ito Shuichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 14
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method