Dry Eye SyndromeNCT01223040
An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye
A study testing SYSTANE® Balance Lubricant Eye Drops in people with Dry Eye Syndrome, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- SYSTANE® Balance Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Sep 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 have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months
Who cannot join
- Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.
About this study
The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.
- Conditions
- Dry Eye Syndrome
- Being tested
- SYSTANE® Balance Lubricant Eye Drops
- 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.
SYSTANE® Balance Lubricant Eye DropsOther
Subjects will be dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.
| Study group | Role | What they receive |
|---|---|---|
| SYSTANE® Balance Lubricant Eye Drops | Experimental | SYSTANE Balance Lubricant Eye Drops dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period. Receives: Other: SYSTANE® Balance Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.
Measured: 8 days
Secondary outcomes (3)
Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8
Measured: 9 days
Fluorescein staining at Visits 1 & 3 on the Ora staining scale
Measured: 9 days
Ocular Symptomology at each visit
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01223040
- Sponsor's protocol ID
- SMA-09-64
- Status last verified
- Jan 2012
- First submitted
- 15 Oct 2010
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye
- ClinicalTrials.gov ID
- NCT01223040
- Acronym / sponsor ID
- SMA-09-64
- Conditions
- Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- First posted
- 18 Oct 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 purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYSTANE® Balance Lubricant Eye Drops | Experimental | Other: SYSTANE® Balance Lubricant Eye DropsSYSTANE Balance Lubricant Eye Drops dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months
Key exclusion criteria (1 listed)
- Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.
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 |
|---|---|---|
| SYSTANE® Balance Lubricant Eye DropsSubjects will be dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period. | Other | SYSTANE® Balance Lubricant Eye Drops |
Primary outcome
Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.
Time frame: 8 days
3 secondary outcomes
Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8
Time frame: 9 days
Fluorescein staining at Visits 1 & 3 on the Ora staining scale
Time frame: 9 days
Ocular Symptomology at each visit
Time frame: 9 days
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 10 Apr 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 SYSTANE® Balance Lubricant Eye Drops in people with Dry Eye 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 1 inclusion and 1 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 10 Apr 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?
Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7. (time frame: 8 days). 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 10 Apr 2012.