Comparison Between Rebamipide 2% Versus Autologous Serum

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608761
• Other study ID #: 055LuPeSo/15
• Status: Completed
• Phase: Phase 4
• Start date: February 6, 2017
• Est. completion date: July 9, 2018

Study information

• Verified date: December 2018
• Source: Hospital Nacional Profesor Alejandro Posadas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 9, 2018
• Est. primary completion date: October 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Sjögren Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Rebamipide
rebamipide 2%

Biological:
• autologous serum
AS for 3 months

Other:
• autologous serum and rebamipide 2%
rebamipide and autologous serum for 3 months

Locations

Country	Name	City	State
Argentina	Hospital Nacional Profesor A. Posadas	El Palomar	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nacional Profesor Alejandro Posadas

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSDI	ocular surface disease index	through study completion, an average of 7 months