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Randomized Study of New Formulation Ophthalmic Cysteamine Hydrochloride for Corneal Cystine Accumulation in Patients With Cystinosis

NCT00010426 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-03-25

No results posted yet for this study

Summary

OBJECTIVES: I. Determine the proportion of patients with cystinosis who experience a serious adverse effect when treated with a new formulation of cysteamine hydrochloride for corneal cystine accumulation.

II. Determine the proportion of patients with a reduction in corneal crystal density of 1.00 unit when treated with this regimen.

Conditions

  • Cystinosis

Interventions

DRUG

cysteamine hydrochloride

Sponsors & Collaborators

  • Leadiant Biosciences, Inc.

    collaborator INDUSTRY

  • FDA Office of Orphan Products Development

    lead FED

Principal Investigators

  • Edward F. Lemanowicz · Leadiant Biosciences, Inc.

Study Design

Purpose
TREATMENT

Eligibility

Min Age
1 Year
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-12-31
Completion
2001-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00010426 on ClinicalTrials.gov