Dry Eye SyndromesPhase 4NCT03608761
Comparison Between Rebamipide 2% Versus Autologous Serum
A Phase 4 study testing Rebamipide, autologous serum and autologous serum and rebamipide 2% in people with Dry Eye Syndromes and Sjögren Syndrome, run by Hospital Nacional Profesor Alejandro Posadas at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dry Eye Syndromes, Sjögren Syndrome
- What is being tested?
- Rebamipide, autologous serum and autologous serum and rebamipide 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteArgentina
- Study dates
- 6 Feb 2017to 9 Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Sjögren's syndrome
- dry eye symtoms
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Nacional Profesor A. Posadas
El Palomar, Buenos Aires, 1684
About this study
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
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
Read the 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.
- Conditions
- Dry Eye Syndromes, Sjögren Syndrome
- Being tested
- Rebamipide, autologous serum, autologous serum and rebamipide 2%
- Keywords
- dry eye, Sjögren syndrome, Rebamipida 2%, autologous serum
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamipideDrug
Also called GR
rebamipide 2%
autologous serumBiological
Also called GSA
AS for 3 months
autologous serum and rebamipide 2%Other
Also called GSAR
rebamipide and autologous serum for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: autologous serum and rebamipide 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
ocular surface disease index
Measured: through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start6 Feb 2017
- Primary completion9 Oct 2017
- Study completion9 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional Profesor Alejandro Posadas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emiliano Fa Ross, MD, Principal investigator, Hospital Nacional Profesor Alejandro Posadas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608761
- Sponsor's protocol ID
- 055LuPeSo/15
- Status last verified
- Dec 2018
- First submitted
- 9 Jul 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03608761
- Acronym / sponsor ID
- 055LuPeSo/15
- Conditions
- Dry Eye Syndromes, Sjögren Syndrome
- Keywords
- dry eye, Sjögren syndrome, Rebamipida 2%, autologous serum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hospital Nacional Profesor Alejandro PosadasUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rebamipide 2% | Experimental | Drug: Rebamipide1. - 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 |
| Autologous serum | Experimental | Biological: autologous serum1. - 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 |
| autologous serum and rebamipide 2% | Experimental | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of Sjögren's syndrome
- dry eye symtoms
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RebamipideAlso: GRrebamipide 2% | Drug | Rebamipide 2% |
| autologous serumAlso: GSAAS for 3 months | Biological | Autologous serum |
| autologous serum and rebamipide 2%Also: GSARrebamipide and autologous serum for 3 months | Other | autologous serum and rebamipide 2% |
Primary outcome
OSDI
Time frame: through study completion, an average of 7 months
ocular surface disease index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emiliano Fa Ross, MD principal investigator
Hospital Nacional Profesor Alejandro Posadas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rebamipide, autologous serum and autologous serum and rebamipide 2% in people with Dry Eye Syndromes and Sjögren Syndrome, run by Hospital Nacional Profesor Alejandro Posadas at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: through study completion, an average of 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.