drugset / Trial / NCT03608761
Comparison Between Rebamipide 2% Versus Autologous Serum
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous serum | Unknown | — | — |
| Subject | Rebamipide | Small molecule | 2 % | — |