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Clinical trial on the effect of Resolvis on ocular surface diseases.


- candidate number10528
- NTR NumberNTR3143
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-nov-2011
- Secondary IDsMDV0705-010-08 
- Public TitleClinical trial on the effect of Resolvis on ocular surface diseases.
- Scientific TitleDouble masked randomized clinical trial on the tolerability and efficacy of Resolvis for the treatment of the ocular surface with qualitative and quantitative changes of the tear film.
- ACRONYM
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedDry eye
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2011
- planned closingdate1-jun-2012
- Target number of participants30
- InterventionsTreatment 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.
- Primary outcomeIncreased stability of the tear film mesured by tear break-up time (BUT).
- Secondary outcomeReduced 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.
- Timepoints7 and 28 days.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Stefano Barabino
- CONTACT for SCIENTIFIC QUERIES Stefano Barabino
- Sponsor/Initiator Medivis srl
- Funding
(Source(s) of Monetary or Material Support)
Medivis srl
- PublicationsRashid S, Jin Y, Ecoiffier T, Barabino S, Schaumberg DA, Dana MR. Topical omega-3 and omega-6 Fatty acids for treatment of dry eye. Arch Ophthalmol 2008;126:219-225.
- Brief summaryAlterations 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.
- Main changes (audit trail)
- RECORD14-nov-2011 - 9-aug-2013


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