Overview

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

Status:
Completed

Trial end date:
2001-02-01

Target enrollment:

Participant gender:

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.

Phase:

N/A

Details

Lead Sponsor:

FDA Office of Orphan Products Development

Collaborators:

Leadiant Biosciences, Inc.
Sigma Tau Pharmaceuticals, Inc.

Treatments:

Cysteamine