Dry eye treatment

• Conditions: Ocular surface disturbances.; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-001556-19-ES
• Lead Sponsor: FUNDACION IMABIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-29
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Dry eye symptoms (red eyes, lid inflammation, discharge, dry eye, sandy and foreign body sensations, burning, itching, discomfort, pricking, tearing and photophobia) for more than three months.
- BUT < 5 seconds or
- Schirmer Test (tipe I) < 5 mm.
- Patients over 18 years old with severe dry eye of all etiologies.
- previous signment of informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

1)Eye-infection or inflammation not related to the dry eye.
2)Contact lens users.
3)Ocular allergy in the past three months.
4)Eyelid and eyelashes malpositions.
5)Pregnant women
6) Positive infectious diseases (haepatitis B and C, HIV and syphilis.
7) Patients with problems related to blood extraction.
8) Patients that have in a clinical trail 30 days prior to the inclusion, in which there has been topical therapy.
9) Patients with chronical therapy with topical corticosteroids.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified