No registrations found.
ID
Source
Health condition
dry eye
Sponsors and support
Intervention
Outcome measures
Primary outcome
Increased stability of the tear film mesured by tear break-up time (BUT).
Secondary outcome
Reduced symptoms (measured by means of a specific questionnaire, ocular surface disease index), and ocular surface signs and inflammation (measured by fluorescin and lissamine green staining of the ocular surface, HLA-DR expression) after treatment of dry eye.
Background summary
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.
Study objective
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.
Study design
7 and 28 days.
Intervention
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.
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. And at least 2 of the following:
A. Schirmer test < 8mm/5 min;
B. BUT <10 sec;
C. Lissamine green staining > or = 3.
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 | NL2995 |
| NTR-old | NTR3143 |
| Other | : MDV0705-010-08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |