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Ocular inflammation and dry eye.


- candidate number7938
- NTR NumberNTR2291
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-apr-2010
- Secondary IDs17/09 METC San Martino Hospital and University Clinics, Genoa, Italy
- Public TitleOcular inflammation and dry eye.
- Scientific TitleMarkers of infllammation expression in conjunctival epithelial cells of dry eye patients.
- ACRONYM
- hypothesisOcular surface inflammation plays a pivotal role in dry eye. The hypothesis of this study is that markers of inflammation expressed by conjunctival epithelial cells can be used to study inflammation and that the topical use of an anti-inflammatory drug such as Loteprednolol etabonate can reduce the level of ocular surface inflammation in dry eye patients.
- Healt Condition(s) or Problem(s) studiedDry eye syndrom
- Inclusion criteria1. Symptoms of dry eye;
2. HLA-DR>15%;
3. And at least 2 of the following:
A. Schirmer test < 8mm/5 min;
B. BUT <10 sec;
C. Lissamine green staining >3.
- Exclusion criteria1. Glaucoma;
2. Ocular surface infections;
3. Corneal ulcer;
4. Conjunctival infections;
5. Treatment with anti-inflammatory drugs 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-jan-2010
- planned closingdate31-dec-2010
- Target number of participants20
- InterventionsTreatment with Loteprednolol etabonate bid (bis in die = 2 times/day) for 14 days, once a day for 14 days and twice a week for 28 days will be given at the study group (N=10).
The control group (N=10) includes patients with symptoms and signs of dry eye as the treated group, but they will undergo the artificial tear (carbossimetilcellulose) with the same posology.
- Primary outcomeReduced level of expression of HLA-DR after treatment with Loteprednolol etabonate measured by flow cytometry.
- Secondary outcomeReduced symptoms (measured by means of a specific questionnaire, ocular surface disease index), and ocular surface signs (measured by fluorescin and lissamine green staining of the ocular surface) after treatment of dry eye.
- Timepoints7, 14, 28 and 56 days.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Stefano Barabino
- CONTACT for SCIENTIFIC QUERIES Stefano Barabino
- Sponsor/Initiator Bausch & Lomb IOM
- Funding
(Source(s) of Monetary or Material Support)
Bausch & Lomb IOM
- PublicationsN/A
- Brief summaryInflammation plays a pivotal role in dry eye pathogenesis. Recently, it has been demonstrated that specific markers of inflammation such as HLA-DR can be used to monitor the degree of inflammation of ocular surface epithelia. The aim of our project is to test the hypothesis that the use of an anti-inflammatory therapy, Loteprednolol etabonate, can significantly reduce the expression of HLA-DR on conjunctival epithelial cells of patients with dry eye when used for prolonged period of time with tapered doses, compared to artificial tears only.
- Main changes (audit trail)
- RECORD15-apr-2010 - 21-nov-2011


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