|
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:
|
12 December 2020 |
|
Main ID: |
NCT03608761 |
|
Date of registration:
|
09/07/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Comparison Between Rebamipide 2% Versus Autologous Serum
|
|
Scientific title:
|
Comparison Between Rebamipide 2% Versus Autologous Serum in the Treatement of the Moderate to Severe Dry Eye Associate With Sjögren Syndrome. Pilot, Crossed, Controled, Randomized And Open Study |
|
Date of first enrolment:
|
February 6, 2017 |
|
Target sample size:
|
21 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03608761 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Argentina
| | | | | | | |
|
Contacts
|
|
Name:
|
Emiliano Fa Ross, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital Nacional Profesor Alejandro Posadas |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- diagnosis of Sjögren's syndrome
- dry eye symtoms
Exclusion Criteria:
- history of ocular surface surgery less than one year or intraocular surgery less than
three months in one or both eyes
- chronic use of drops in one of both eyes (e.g. : treatment for glaucoma)
- anterior segment disease (ocular scar pemphigoid, Stenvens Jhonson syndrome)
- presence of punctung plug (lacrimal plug) inserted in one or both lower lacrimal
points
- systemic viral infections (Hepatitis B, Hepatitis C, HIV)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Sjögren Syndrome
|
|
Dry Eye Syndromes
|
|
Intervention(s)
|
|
Drug: Rebamipide
|
|
Biological: autologous serum
|
|
Other: autologous serum and rebamipide 2%
|
|
Primary Outcome(s)
|
|
OSDI
[Time Frame: through study completion, an average of 7 months]
|
|
Secondary ID(s)
|
|
055LuPeSo/15
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|