The hypothesis of this study is that omega 3 fatty acid in an artificial tear ameliorates symptoms and ocular surface signs in patients with dry eye.
ID
Bron
Aandoening
dry eye
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Increased stability of the tear film mesured by tear break-up time (BUT).
Achtergrond van het onderzoek
Alterations of the tear film induce ocular surface changes and determine frequent diseases such as dry eye. Omega 3 fatty acid have been demonstrated to be effective in treating dry eye and improving ocular surface conditions when administered orally in humens and topically in a mouse model of dry eye. This study for the first time analyzes the effect of a topical therapy with omega 3 in a double masked randomized clinical trial.
Doel van het onderzoek
The hypothesis of this study is that omega 3 fatty acid in an artificial tear ameliorates symptoms and ocular surface signs in patients with dry eye.
Onderzoeksopzet
7 and 28 days.
Onderzoeksproduct en/of interventie
Treatment with Resolvis (bis in die = 2 times/day) for 28 days will be given at the study group (N=15).
The control group (N=15) includes patients with symptoms and signs of dry eye as the treated group, but they will undergo the saline solution with the same posology.
Publiek
Stefano Barabino
Geneva 16132
Italy
+39 010 35338294
barabino@schepens.harvard.edu
Wetenschappelijk
Stefano Barabino
Geneva 16132
Italy
+39 010 35338294
barabino@schepens.harvard.edu
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Symptoms of dry eye;
2. And at least 2 of the following:
A. Schirmer test < 8mm/5 min;
B. BUT <10 sec;
C. Lissamine green staining > or = 3.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2995 |
NTR-old | NTR3143 |
Ander register | : MDV0705-010-08 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |