JPRN-jRCTs031220490
Recruiting
Phase 3
An open-label, single-arm study to develop a novel ophthalmic testing method in patients with cystinosis
Yamamoto Yuuka0 sites6 target enrollmentDecember 5, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cystinosis
- Sponsor
- Yamamoto Yuuka
- Enrollment
- 6
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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