Sjogren's SyndromeNCT01079871
Evaluation of FID 114657 in Sjogren's Syndrome Subjects
A study testing FID 114657 (ORB Preserved Ocular Emulsion) in people with Sjogren's Syndrome, run by Alcon Research.
Trial summary
The primary objective of this study is to assess the overall Sjogren's Syndrome subject's preference for a particular product. Dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- FID 114657 (ORB Preserved Ocular Emulsion)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Jun 2010
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be at least 18 years of age, must read and sign the informed consent form (ICF), and must agree to comply with the study requirements.
- Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye, must report having an ocular examination in the last two years and must be using topical ocular dry eye therapy (artificial tears or Restasis) at least 4 times per day.
- Patients must have been diagnosed with Sjogren's Syndrome (confirmed or consistent with the American-European Consensus Criteria 2002).
Who cannot join
- Patients cannot wear contact lenses within one week prior to visit 1 and cannot wear their contact lenses during the study.
- Patients cannot have a history of hypersensitivity to any component of FID 114657, and cannot have diabetes (Type 1 or 2).
- Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have an eyelid abnormality that might affect lid function.
- Patients cannot have punctal plugs that were placed less than or equal to 30 days prior to Visit 1, and cannot have active infections or inflammations not associated with Sjogren's Syndrome.
- They cannot have started or changed the dose of chronic systemic medication within 7 days prior to visit 1, and must remain on a stable dosing regimen for the duration of the study.
- Patients cannot have participated in another investigational clinical or research study within 30 days of visit 1 and are not allowed to participate in any other drug or device clinical trial for the duration of this study.
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- Patients cannot have any findings in the vitreous, retina, macula and choroid that show signs of active inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant and/or a score of greater than 0 for the optic nerve.
- Patients can not have had punctal cauterization within 30 days prior to Visit 1, have a history of undergoing prior cataract surgery with complications as a result of the cataract surgery.
- Participants who have undergone prior cataract surgery without complications must be at least six months post-op with a stable refractive error.
- Patients cannot have received ocular prescription therapy in the last 30 days (Restasis can be used as long as stable for at least 30 days).
About this study
The primary objective of this study is to assess the overall Sjogren's Syndrome subject's preference for a particular product. Dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires.
- Conditions
- Sjogren's Syndrome
- Being tested
- FID 114657 (ORB Preserved Ocular Emulsion)
- Keywords
- Sjogren's Syndrome, Dry Eye
- Medical subject headings
- Sjogren's Syndrome, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID 114657 (ORB Preserved Ocular Emulsion)Other
Patients will dose as needed throughout the day (PRN) for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| FID 114657 (ORB Preserved Ocular Emulsion) | Experimental | ORB Preserved Ocular Emulsion dosed as needed throughout the day (PRN) Receives: Other: FID 114657 (ORB Preserved Ocular Emulsion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference based on subject's relief of dry eye
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079871
- Sponsor's protocol ID
- SMA-09-65
- Status last verified
- Jan 2012
- First submitted
- 2 Mar 2010
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of FID 114657 in Sjogren's Syndrome Subjects
- ClinicalTrials.gov ID
- NCT01079871
- Acronym / sponsor ID
- SMA-09-65
- Conditions
- Sjogren's Syndrome
- Keywords
- Sjogren's Syndrome, Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jun 2010 (actual)
- First posted
- 3 Mar 2010 (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.
The primary objective of this study is to assess the overall Sjogren's Syndrome subject's preference for a particular product. Dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FID 114657 (ORB Preserved Ocular Emulsion) | Experimental | Other: FID 114657 (ORB Preserved Ocular Emulsion)ORB Preserved Ocular Emulsion dosed as needed throughout the day (PRN) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be at least 18 years of age, must read and sign the informed consent form (ICF), and must agree to comply with the study requirements.
- Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye, must report having an ocular examination in the last two years and must be using topical ocular dry eye therapy (artificial tears or Restasis) at least 4 times per day.
- Patients must have been diagnosed with Sjogren's Syndrome (confirmed or consistent with the American-European Consensus Criteria 2002).
Key exclusion criteria (10 listed)
- Patients cannot wear contact lenses within one week prior to visit 1 and cannot wear their contact lenses during the study.
- Patients cannot have a history of hypersensitivity to any component of FID 114657, and cannot have diabetes (Type 1 or 2).
- Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have an eyelid abnormality that might affect lid function.
- Patients cannot have punctal plugs that were placed less than or equal to 30 days prior to Visit 1, and cannot have active infections or inflammations not associated with Sjogren's Syndrome.
- They cannot have started or changed the dose of chronic systemic medication within 7 days prior to visit 1, and must remain on a stable dosing regimen for the duration of the study.
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 |
|---|---|---|
| FID 114657 (ORB Preserved Ocular Emulsion)Patients will dose as needed throughout the day (PRN) for 4 weeks. | Other | FID 114657 (ORB Preserved Ocular Emulsion) |
Primary outcome
Preference based on subject's relief of dry eye
Time frame: 5 weeks
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 2 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FID 114657 (ORB Preserved Ocular Emulsion) in people with Sjogren's Syndrome, run by Alcon Research.
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 3 inclusion and 10 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Preference based on subject's relief of dry eye (time frame: 5 weeks). 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 2 Feb 2012.