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Comparison Between Rebamipide 2% Versus Autologous Serum

NCT03608761 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-12-04

No results posted yet for this study

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

Conditions

  • Dry Eye Syndromes
  • Sjögren Syndrome

Interventions

DRUG

Rebamipide

rebamipide 2%

BIOLOGICAL

autologous serum

AS for 3 months

OTHER

autologous serum and rebamipide 2%

rebamipide and autologous serum for 3 months

Sponsors & Collaborators

  • Hospital Nacional Profesor Alejandro Posadas

    lead OTHER

Principal Investigators

  • Emiliano Fa Ross, MD · Hospital Nacional Profesor Alejandro Posadas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03608761 on ClinicalTrials.gov