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Ocular inflammation and dry eye.

Markers of infllammation expression in conjunctival epithelial cells of dry eye patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26452
Enrollment
20
Registered
2010-04-15
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dry eye syndrome

Interventions

Treatment 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

Sponsors

University of Genoa, viale Benedetto XV, 5, 16132 Genova, Italy, tel. +39-010-3538455 Bausch & Lomb IOM Dott. Sebastiano Giuffrida via Senigallia 18 20161 Milano
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Symptoms of dry eye; 2. HLA-DR>15%; 3. And at least 2 of the following: A. Schirmer test 3.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
Reduced level of expression of HLA-DR after treatment with Loteprednolol etabonate measured by flow cytometry.

Secondary

MeasureTime frame
Reduced 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.

Contacts

Public ContactStefano Barabino

Viale Benedetto XV, 5

barabino@schepens.harvard.edu+39 010 35338294

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)