Comparison Between Rebamipide 2% Versus Autologous Serum

• Status: Completed
• Trial end date: 2018-07-09
• Target enrollment: 0
• Participant gender: Female

Summary

Two-period, controlled, randomized and open clinical trial. The sample was composed of adult women with moderate to severe hypo secretory dry eye associated with Sjögren's syndrome, who attended the ocular surface office, derived from the general ophthalmology clinic, from the Rheumatology or Immunology department. The three interventions were randomized: autologous serum (GSA), Rebamipida 2% (GR) and a combined treatment (GSAR). The following were used as outcome measures: OSDI self-administered questionnaire (Ocular Surface Disease Index), tear-rupture time (BUT), fluorescein staining, Bengal Rose staining and Schirmer's test without anesthesia to assess the answer to each treatment

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Nacional Profesor Alejandro Posadas
• Treatments: Rebamipide

Criteria

Inclusion Criteria:

• diagnosis of Sjögren's syndrome

• dry eye symtoms

Exclusion Criteria:

• history of ocular surface surgery less than one year or intraocular surgery less than three months in one or both eyes

• chronic use of drops in one of both eyes (e.g. : treatment for glaucoma)

• anterior segment disease (ocular scar pemphigoid, Stenvens Jhonson syndrome)

• presence of punctung plug (lacrimal plug) inserted in one or both lower lacrimal points

• systemic viral infections (Hepatitis B, Hepatitis C, HIV)