NCT03608761

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

July 9, 2018

Last Update Submit

December 2, 2018

Conditions

Dry Eye SyndromesSjögren Syndrome

Keywords

dry eyeSjögren syndromeRebamipida 2%autologous serum

Outcome Measures

Primary Outcomes (1)

  • OSDI

    ocular surface disease index

    through study completion, an average of 7 months

Study Arms (3)

Rebamipide 2%

EXPERIMENTAL

1. \- wash-out: 2 weeks 2. \- rebamipide 2% four times a day for 3 months 3. \- controls will be taken at day zero, 30 and 90. 4. \- wash-out: 2 weeks 5. \- autologous serum for 3 months

Drug: Rebamipide

Autologous serum

EXPERIMENTAL

1. \- wash-out: 2 weeks 2. \- autologous serum four times a day for 3 months 3. \- controls will be taken at day zero, 30 and 90. 4. \- wash-out: 2 weeks 5. \- rebamipe 2% for 3 months

Biological: autologous serum

autologous serum and rebamipide 2%

EXPERIMENTAL

rebamipide 2% and autologous serum four times a day for 3 months separately by 1 minute between each other controls will be taken at day zero, 30 and 90. this group will not be crossed

Other: autologous serum and rebamipide 2%

Interventions

RebamipideDRUG

rebamipide 2%

Also known as: GR
Rebamipide 2%
autologous serumBIOLOGICAL

AS for 3 months

Also known as: GSA
Autologous serum
autologous serum and rebamipide 2%OTHER

rebamipide and autologous serum for 3 months

Also known as: GSAR
autologous serum and rebamipide 2%

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Sjögren's syndrome
  • dry eye symtoms

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nacional Profesor A. Posadas

El Palomar, Buenos Aires, 1684, Argentina

Location

MeSH Terms

Conditions

Dry Eye SyndromesSjogren's Syndrome

Interventions

rebamipide

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Emiliano Fa Ross, MD

    Hospital Nacional Profesor Alejandro Posadas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 1, 2018

Study Start

February 6, 2017

Primary Completion

October 9, 2017

Study Completion

July 9, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)