Primary Sjogren SyndromePhase 4NCT02004067
Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
A Phase 4 study testing Restasis and Refresh Endura in people with Primary Sjogren Syndrome and Secondary Sjogren Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
In the present study the investigators aim to determine the efficacy of an immunomodulating topical medication, compared with a topical lubricant, on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Sjogren Syndrome, Secondary Sjogren Syndrome, Aqueous Deficient Dry Eye Disease
- What is being tested?
- Restasis and Refresh Endura
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Aug 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed for mild to moderate Aqueous Deficient DED (ADDED), defined as Schirmer 1 < 10mm;
- Patients diagnosed for mild to moderate Evaporative DED (EDED), defined as normal Schirmer 1 and BUT < 5 seconds;
- Patients submitted to refractive surgery,
- Patients capable of understanding instructions, signing the term of consent and available to attend all exam visits.
Who cannot join
- patients with punctual occlusion,
- active ocular infection or inflammatory disease,
- history of herpetic keratitis,
- contact lens use during trial period,
- patients with glaucoma,
- any eyelid globe malposition abnormality.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Departamento de Oftalmologia da Escola Paulista de Medicina - UNIFESP
São Paulo, São Paulo, 04023 062
About this study
In the present study the investigators aim to determine the efficacy of an immunomodulating topical medication, compared with a topical lubricant, on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.
Read the detailed description
Dry eye disease (DED) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. DED prevalence is estimated around 15 -35% of the population over 50 years old. There is a wide variety of topic medications for the treatment of DED, though few aim the re-establishment of tear osmolarity equilibrium and reduction of damages to the ocular surface. The treatment of DED can include a medical treatment, such as tear substitution, tear preservation, production stimulation, anti-inflammatory; it can also include surgical treatment, as tarsorrhaphy and salivary gland transplant. Considering tear substitutes and anti-inflammatory topical treatments, the purpose of our study is to determine efficacy of an immunomodulating topical medication containing 0.05% cyclosporine A (CsA), compared to a topical lubricant (vitamin A, Refresh Endura®), on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.
- Conditions
- Primary Sjogren Syndrome, Secondary Sjogren Syndrome, Aqueous Deficient Dry Eye Disease, Evaporative Dry Eye Disease
- Being tested
- Restasis, Refresh Endura
- Keywords
- Evaporative, Aqueous deficient, Dry eye disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestasisDrug
Also called Cyclosporine 0.05%
Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.
Refresh EnduraDrug
Also called Castor oil
Refresh Endura is a topical lubricant produced by Allergan, Inc.
| Study group | Role | What they receive |
|---|---|---|
| Refresh Endura | Active comparator | Topical lubricant containing (glycerin; polysorbate 80; castor oil; carbomer, boric acid, sodium hydroxide, purified water), one drop 2 times a day, for 3 months. Receives: Drug: Refresh Endura |
| Restasis | Experimental | Topical immunomodulatory lubricant (Ophthalmic emulsion containing cyclosporine 0.5 mg/mL, i.e., 0.05%), one drop 2 times a day, for 3 months Receives: Drug: Restasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface inflammation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjogren SyndromeStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Rossen Mihaylov Hazarbassanov, MD, PhD, Federal University of São Paulo
- Investigators
- Rossen M Hazarbassanov, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004067
- Sponsor's protocol ID
- 17821013.0.0000.5505
- Status last verified
- Sep 2020
- First submitted
- 3 Dec 2013
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT02004067
- Acronym / sponsor ID
- 17821013.0.0000.5505
- Conditions
- Primary Sjogren Syndrome, Secondary Sjogren Syndrome, Aqueous Deficient Dry Eye Disease, Evaporative Dry Eye Disease
- Keywords
- Evaporative, Aqueous deficient, Dry eye disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Dec 2013 (estimated)
- 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.
In the present study the investigators aim to determine the efficacy of an immunomodulating topical medication, compared with a topical lubricant, on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.
Detailed description
Dry eye disease (DED) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. DED prevalence is estimated around 15 -35% of the population over 50 years old. There is a wide variety of topic medications for the treatment of DED, though few aim the re-establishment of tear osmolarity equilibrium and reduction of damages to the ocular surface. The treatment of DED can include a medical treatment, such as tear substitution, tear preservation, production stimulation, anti-inflammatory; it can also include surgical treatment, as tarsorrhaphy and salivary gland transplant. Considering tear substitutes and anti-inflammatory topical treatments, the purpose of our study is to determine efficacy of an immunomodulating topical medication containing 0.05% cyclosporine A (CsA), compared to a topical lubricant (vitamin A, Refresh Endura®), on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refresh Endura | Active comparator | Drug: Refresh EnduraTopical lubricant containing (glycerin; polysorbate 80; castor oil; carbomer, boric acid, sodium hydroxide, purified water), one drop 2 times a day, for 3 months. |
| Restasis | Experimental | Drug: RestasisTopical immunomodulatory lubricant (Ophthalmic emulsion containing cyclosporine 0.5 mg/mL, i.e., 0.05%), one drop 2 times a day, for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed for mild to moderate Aqueous Deficient DED (ADDED), defined as Schirmer 1 < 10mm;
- Patients diagnosed for mild to moderate Evaporative DED (EDED), defined as normal Schirmer 1 and BUT < 5 seconds;
- Patients submitted to refractive surgery,
- Patients capable of understanding instructions, signing the term of consent and available to attend all exam visits.
Key exclusion criteria (6 listed)
- patients with punctual occlusion,
- active ocular infection or inflammatory disease,
- history of herpetic keratitis,
- contact lens use during trial period,
- patients with glaucoma,
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 |
|---|---|---|
| RestasisAlso: Cyclosporine 0.05%Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc. | Drug | Restasis |
| Refresh EnduraAlso: Castor oilRefresh Endura is a topical lubricant produced by Allergan, Inc. | Drug | Refresh Endura |
Primary outcome
Ocular surface inflammation
Time frame: 3 months
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 22 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Rossen M Hazarbassanov, PhD principal investigator
Federal University of São Paulo
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 Restasis and Refresh Endura in people with Primary Sjogren Syndrome and Secondary Sjogren Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 6 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 22 Sep 2020. 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 Brazil. 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?
Ocular surface inflammation (time frame: 3 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 22 Sep 2020.