Cystinosis
Conditions
Interventions
Administration of A0003 Eye Drops 0.55% 4 times day
Sponsors
Ito Shuichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IVCM Total Score by in vivo confocal microscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Luminance waveform analysis (LWA) by AS-OCT Photophobia rated by investigators Photophobia rated by patients | — |
Contacts
Public ContactYoko Sugihara
Viatris Inc.
Outcome results
None listed