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

An open-label, single-arm study to develop a novel ophthalmic testing method in patients with cystinosis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031220490
Enrollment
6
Registered
2022-12-05
Start date
2022-12-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystinosis Cystinosis

Interventions

Administration of A0003 Eye Drops 0.55% 4 times day for 52 weeks
cysteamine eyedrops

Sponsors

Yamamoto Yuuka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Luminance waveform analysis (LWA) by using AS-OCT

Secondary

MeasureTime frame
Photophobia rated by investigators Photophobia rated by patients

Contacts

Public ContactTadashi Okamura

Reserch Insitute, the National Center for GlobalHealth and Medicine

okamurat@ri.ncgm.go.jp+81-3-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026