drugset / Trial / NCT03608761

Comparison Between Rebamipide 2% Versus Autologous Serum

NCT03608761

Phase 4 Completed 21 enrolled Hospital Nacional Profesor Alejandro Posadas
RandomizedCrossoverSingle-blindTreatment

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

Timeline

Start
2017-02-06
Primary completion
2017-10-09
Completion
2018-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous serum Unknown
Subject Rebamipide Small molecule 2 %