Comparison Between Rebamipide 2% Versus Autologous Serum

Comparison Between Rebamipide 2% Versus Autologous Serum in the Treatement of the Moderate to Severe Dry Eye Associate With Sjögren Syndrome. Pilot, Crossed, Controled, Randomized And Open Study

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Sjögren Syndrome
• Intervention / Treatment: Drug: Rebamipide; Biological: autologous serum; Other: autologous serum and rebamipide 2%

Detailed Description

After having borrowed to participate in the study, we proceeded to the random assignment of each intervention as follow: the last 2 numbers of the clinical history, typical of the ocular surface office, were taken and they were placed in a list in order of lower to higher. Then, each of them was assigned to a number from a table of random numbers. The list was rearranged from lowest to highest using the assigned random number. Finally, the treatment was assigned by simple randomization without replacement. In this way, the subject with the lowest random number, the correspondence in the first treatment drawn. It was continued in the same way, respecting the order assigned by random numbers until completing the 21 subjects.

Three groups of 7 subjects each were formed in this way: treatment group or group Rebamipida (GR); standard treatment group or autologous serum group (GSA) and mixed group or serum and Rebamipide group (GSAR).

Before beginning with the assigned treatment, all the participants was started a period of wash-out of any medicine they were ussing, that least for two weeks. The participants were asked to suspend all the drops that they been used until then (antibiotics, corticosteroids, cyclosporine, artificial tears, autologous serum, etc.), and to place them using only artificial tears (sodium carboxymethyl cellulose). 1%, AUCIC 1%) four times a day in all cases. The purpose was to minimize the effect of the medication that could interfere with the results obtained from the treatments tested. The two week period also allowed the hemotherapy service to prepare the autologous serum for the subjects assigned to this group and initiate the treatment without delays.

Immediately after the washout period, the subjects began to receive the last treatments for 90 days.

After the first intervention cycle and with the objective of influencing the treatment cycle of the first treatment cycle, a second washing period of two weeks duration was carried out.

With the intention of increasing the sample size, the GR and GSA groups were crossed, in this way the patients received the opposite treatment to the start. The second treatment period lasted 90 days, equal to the first.

The mixed group (GSAR) did not cross, ending their participation at the end of the 90 days.

Admission and control of all patients on days 0, 30 and 90 of both cycles were performed by the same ophthalmologist.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • El Palomar, Buenos Aires, Argentina, 1684
      • Hospital Nacional Profesor A. Posadas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rebamipide 2%; - wash-out: 2 weeks; - rebamipide 2% four times a day for 3 months; - controls will be taken at day zero, 30 and 90.; - wash-out: 2 weeks; - autologous serum for 3 months	Drug: Rebamipide; rebamipide 2%; Other Names: GR
Experimental: Autologous serum; - wash-out: 2 weeks; - autologous serum four times a day for 3 months; - controls will be taken at day zero, 30 and 90.; - wash-out: 2 weeks; - rebamipe 2% for 3 months	Biological: autologous serum; AS for 3 months; Other Names: GSA
Experimental: autologous serum and rebamipide 2%; 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%; rebamipide and autologous serum for 3 months; Other Names: GSAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI	ocular surface disease index	through study completion, an average of 7 months

Collaborators and Investigators

• Sponsor: Hospital Nacional Profesor Alejandro Posadas
• Investigators: Principal Investigator: Emiliano Fa Ross, MD, Hospital Nacional Profesor Alejandro Posadas

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): October 9, 2017
• Study Completion (Actual): July 9, 2018

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 2, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: dry eye; Sjögren syndrome; Rebamipida 2%; autologous serum
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Rebamipide
• Other Study ID Numbers: 055LuPeSo/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No