No registrations found.
ID
Source
Health condition
dry eye syndrome
Sponsors and support
viale Benedetto XV, 5, 16132 Genova, Italy, tel. +39-010-3538455
Bausch & Lomb IOM
Dott. Sebastiano Giuffrida
via Senigallia 18
20161 Milano
Intervention
Outcome measures
Primary outcome
Reduced level of expression of HLA-DR after treatment with Loteprednolol etabonate measured by flow cytometry.
Secondary outcome
Reduced symptoms (measured by means of a specific questionnaire, ocular surface disease index), and ocular surface signs (measured by fluorescin and lissamine green staining of the ocular surface) after treatment of dry eye.
Background summary
Inflammation plays a pivotal role in dry eye pathogenesis. Recently, it has been demonstrated that specific markers of inflammation such as HLA-DR can be used to monitor the degree of inflammation of ocular surface epithelia. The aim of our project is to test the hypothesis that the use of an anti-inflammatory therapy, Loteprednolol etabonate, can significantly reduce the expression of HLA-DR on conjunctival epithelial cells of patients with dry eye when used for prolonged period of time with tapered doses, compared to artificial tears only.
Study objective
Ocular surface inflammation plays a pivotal role in dry eye. The hypothesis of this study is that markers of inflammation expressed by conjunctival epithelial cells can be used to study inflammation and that the topical use of an anti-inflammatory drug such as Loteprednolol etabonate can reduce the level of ocular surface inflammation in dry eye patients.
Study design
7, 14, 28 and 56 days.
Intervention
Treatment with Loteprednolol etabonate bid (bis in die = 2 times/day) for 14 days, once a day for 14 days and twice a week for 28 days will be given at the study group (N=10).
The control group (N=10) includes patients with symptoms and signs of dry eye as the treated group, but they will undergo the artificial tear (carbossimetilcellulose) with the same posology.
Stefano Barabino
Geneva 16132
Italy
+39 010 35338294
barabino@schepens.harvard.edu
Stefano Barabino
Geneva 16132
Italy
+39 010 35338294
barabino@schepens.harvard.edu
Inclusion criteria
1. Symptoms of dry eye;
2. HLA-DR>15%;
3. And at least 2 of the following:
A. Schirmer test < 8mm/5 min;
B. BUT <10 sec;
C. Lissamine green staining >3.
Exclusion criteria
1. Glaucoma;
2. Ocular surface infections;
3. Corneal ulcer;
4. Conjunctival infections;
5. Treatment with anti-inflammatory drugs in the 3 months preceding the study;
6. Surgical procedures in the 3 months preceding the study;
7. Antiglaucoma therapies;
8. Contact lens use 7 days before the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2167 |
| NTR-old | NTR2291 |
| Other | METC San Martino Hospital and University Clinics, Genoa, Italy : 17/09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |