|
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: |
NCT02004067 |
|
Date of registration:
|
03/12/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
|
|
Scientific title:
|
Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease |
|
Date of first enrolment:
|
January 2013 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02004067 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
Rossen M Hazarbassanov, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Federal University of São Paulo |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients diagnosed for mild to moderate Aqueous Deficient DED (ADDED), defined as
Schirmer 1 < 10mm;
- Patients diagnosed for mild to moderate Evaporative DED (EDED), defined as normal
Schirmer 1 and BUT < 5 seconds;
- Patients submitted to refractive surgery,
- Patients capable of understanding instructions, signing the term of consent and
available to attend all exam visits.
Exclusion Criteria:
- patients with punctual occlusion,
- active ocular infection or inflammatory disease,
- history of herpetic keratitis,
- contact lens use during trial period,
- patients with glaucoma,
- any eyelid globe malposition abnormality.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Evaporative Dry Eye Disease
|
|
Aqueous Deficient Dry Eye Disease
|
|
Primary Sjogren Syndrome
|
|
Secondary Sjogren Syndrome
|
|
Intervention(s)
|
|
Drug: Restasis
|
|
Drug: Refresh Endura
|
|
Primary Outcome(s)
|
|
Ocular surface inflammation
[Time Frame: 3 months]
|
|
Secondary ID(s)
|
|
17821013.0.0000.5505
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|