Dry EyePhase 4NCT01086774
Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects
A Phase 4 study testing Systane Ultra Lubricant Eye Drops in people with Dry Eye, run by Alcon Research.
Trial summary
Evaluation of the optical effects of Systane Ultra Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Systane Ultra Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Nov 2010
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or more.
- Subjects must have Tear Break Up Time (TBUT) < 5 seconds
- Subjects must have a maximum blink interval (MBI) < 10 seconds
- Subjects must be willing to comply with all study requirements.
- Subjects must understand, sign and be given a copy of the written Informed Consent form.
Who cannot join
- Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
- Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
- Subjects with known sensitivity to planned study concomitant medications
- Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
- Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication
About this study
Evaluation of the optical effects of Systane Ultra
- Conditions
- Dry Eye
- Being tested
- Systane Ultra Lubricant Eye Drops
- Keywords
- Dry eye, Tear Film Stability
- 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 Ultra Lubricant Eye DropsOther
Single drop in both eyes
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra | Experimental | Systane Ultra Lubricant Eye Drops Receives: Other: Systane Ultra Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in maximum blink interval (MBI)
Measured: 1 day
Secondary outcomes (1)
Tear film stability and contrast sensitivity
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT01086774
- Sponsor's protocol ID
- SMA-09-39
- Status last verified
- Jan 2012
- First submitted
- 12 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
- Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects
- ClinicalTrials.gov ID
- NCT01086774
- Acronym / sponsor ID
- SMA-09-39
- Conditions
- Dry Eye
- Keywords
- Dry eye, Tear Film Stability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- First posted
- 15 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.
Evaluation of the optical effects of Systane Ultra
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra | Experimental | Other: Systane Ultra Lubricant Eye DropsSystane Ultra Lubricant Eye Drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or more.
- Subjects must have Tear Break Up Time (TBUT) < 5 seconds
- Subjects must have a maximum blink interval (MBI) < 10 seconds
- Subjects must be willing to comply with all study requirements.
- Subjects must understand, sign and be given a copy of the written Informed Consent form.
Key exclusion criteria (5 listed)
- Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
- Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
- Subjects with known sensitivity to planned study concomitant medications
- Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
- Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication
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 Ultra Lubricant Eye DropsSingle drop in both eyes | Other | Systane Ultra |
Primary outcome
Improvement in maximum blink interval (MBI)
Time frame: 1 day
1 secondary outcome
Tear film stability and contrast sensitivity
Time frame: 1 day
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 Phase 4 study testing Systane Ultra Lubricant Eye Drops in people with Dry Eye, 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 5 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 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.
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?
Improvement in maximum blink interval (MBI) (time frame: 1 day). 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.