Randomized Study of New Formulation Ophthalmic Cysteamine Hydrochloride for Corneal Cystine Accumulation in Patients With Cystinosis
|ClinicalTrials.gov Identifier: NCT00010426|
Recruitment Status : Completed
First Posted : February 2, 2001
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment|
|Cystinosis||Drug: cysteamine hydrochloride|
PROTOCOL OUTLINE: This is a randomized, multicenter study Patients are randomized to receive the current formulation of cysteamine hydrochloride as drops in one eye and the new formulation of cysteamine hydrochloride as drops in the other eye.
Patients receive the two formulations of cysteamine hydrochloride in their assigned eyes every hour during waking hours daily for 6 months (safety study) or for 1 year (efficacy study).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Study Start Date :||December 1999|
|Estimated Study Completion Date :||February 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010426
|Study Chair:||Edward F. Lemanowicz||Leadiant Biosciences, Inc.|