|- candidate number||10678|
|- NTR Number||NTR3192|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-dec-2011|
|- Secondary IDs||9/2011 METC|
|- Public Title||Clinical trial on the effect of Azyter in patients with blepharitis.|
|- Scientific Title||The effect of azithromicin ophthalmic solution on symptoms, signs, and markers of inflammation in patients with blepharitis.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Blepharitis|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-dec-2011|
|- planned closingdate||15-jun-2012|
|- Target number of participants||30|
|- Interventions||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.
|- 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.|
|- Timepoints||7 and 21 days.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Stefano Barabino|
|- CONTACT for SCIENTIFIC QUERIES|| Stefano Barabino|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Publications||Opitz DL, Tyler KF. Efficacy of azithromycin 1% ophthalmic solution for treatment of ocular surface disease from posterior blepharitis.
Clin Exp Optom. 2011 Mar;94(2):200-6.
|- Brief 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.|
|- Main changes (audit trail)|
|- RECORD||12-dec-2011 - 9-aug-2013|