No registrations found.
ID
Source
Health condition
Blepharitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of HLA-DR expression levels after treatment with Azyter.
Secondary outcome
Symptoms and signs of blepharitis, and level of cytokines in tears after treatment with Azyter.
Background summary
Blepharitis is a disease of the ocular surface which affects a growing number of patients, and to date there are no definitive treatments available. Inflammation plays a pivotal role in dry eye and possibly in blepharitis. Therefore, we hypothesize that the use of an antibiotic with anti-inflammatory activity may improve symptoms and signs of blepharitis and to reduce the level of ocular surface inflammation mesured as expression of inflammatory cell markers and quantity of inflammatory cytokines in tears.
Study objective
Ocular surface inflammation plays a pivotal role in dry eye and possibly in blepharitis. We hypothesize that the quantity of pro-inflammatory cytokines in tears and the expression of markers of inflammation on conjunctival cells are increased in patients with blepharitis. Furthermore, the aim of our project is to evaluate the effect of topical treatment with Azithromycin on symptoms, clinical signs, and ocular surface inflammation induced by blepharitis.
Study design
7 and 21 days.
Intervention
Treatment with Azyter 2 times/day for 3 days and once/day for 3 days will be given at the study group (N=15).
The control group (N=15) includes patients with symptoms and signs of blepharitis as the treated group, but they will undergo the saline solution 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 blepharitis;
2. HLA-DR > 15% on conjunctival cells;
3. BUT <10 sec;
4. lid margin hyperemia >=2;
5. Meibum quality >= 10.
Exclusion criteria
1. Glaucoma;
2. Ocular surface infections;
3. Corneal ulcer;
4. Conjunctival infections;
5. Treatment with anti-inflammatory drugs and cyclosporine 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 | NL3044 |
| NTR-old | NTR3192 |
| Other | METC : 9/2011 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
Clin Exp Optom. 2011 Mar;94(2):200-6.