|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00001213 |
|
Date of registration:
|
03/11/1999 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Cysteamine Eye Drops to Treat Corneal Crystals in Cystinosis
|
|
Scientific title:
|
Trial of Topical Cysteamine in the Treatment of Corneal Cystine Crystal Accumulation in Cystinosis |
|
Date of first enrolment:
|
April 1986 |
|
Target sample size:
|
328 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00001213 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Rachel J Bishop, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National Eye Institute (NEI) |
| | |
|
Key inclusion & exclusion criteria
|
INCLUSION CRITERIA:
- Patients must have a documented clinical diagnosis of cystinosis.
- Patients should be 2 years old or older.
EXCLUSION CRITERIA:
- Inability to travel to NIH for a baseline examination, after 1 year, and every two
years thereafter for follow-up
- Inability to cooperate for slit-lamp examination
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystinosis
|
|
Intervention(s)
|
|
Drug: Cysteamine
|
|
Primary Outcome(s)
|
|
Number of Eyes With a Corneal Cystine Crystal Score (CCCS) Response
[Time Frame: Any Time Point Up to 19 Years]
|
|
Number of Participants With Serious and Non-Serious Adverse Events
[Time Frame: Any Time Point up to 27 Years]
|
|
Secondary ID(s)
|
|
86-EI-0062
|
|
860062
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|