Dry EyeNCT01417013
Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
A study testing Systane Ultra and Optive in people with Dry Eye, run by Alcon Research.
Trial summary
The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects. 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 and Optive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Jan 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Corrected VA of 0.6 LogMar or better OU
Who cannot join
- Topical ocular medication use
- Presence of Ocular conditions (blepharitis, conjunctival infections, etc)
About this study
Official title: A Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects.
Read the detailed description
The primary objective of this study is assess the tear film break-up time in mild to moderate dry eye subjects.
- Conditions
- Dry Eye
- Being tested
- Systane Ultra, Optive
- Keywords
- Dry eye or 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 UltraOther
Also called Systane Ultra Lubricant Eye Drops
Lubricant Eye Drops
OptiveOther
Also called Optive Lubricant eye drops
Lubricant eye drops
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra | Active comparator | Systane Ultra Lubricant Eye Drops Receives: Other: Systane Ultra |
| Optive | Active comparator | Optive Lubricant eye drops Receives: Other: Optive |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBUT
Tear Film break-up time
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Management Decision
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 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
- NCT01417013
- Sponsor's protocol ID
- SMA-10-07
- Status last verified
- Feb 2012
- First submitted
- 12 Aug 2011
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
- ClinicalTrials.gov ID
- NCT01417013
- Acronym / sponsor ID
- SMA-10-07
- Conditions
- Dry Eye
- Keywords
- Dry eye or lubricant eye drops
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Aug 2011 (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 assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects.
Detailed description
The primary objective of this study is assess the tear film break-up time in mild to moderate dry eye subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra | Active comparator | Other: Systane UltraSystane Ultra Lubricant Eye Drops |
| Optive | Active comparator | Other: OptiveOptive Lubricant eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Corrected VA of 0.6 LogMar or better OU
Key exclusion criteria (2 listed)
- Topical ocular medication use
- Presence of Ocular conditions (blepharitis, conjunctival infections, etc)
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 UltraAlso: Systane Ultra Lubricant Eye DropsLubricant Eye Drops | Other | Systane Ultra |
| OptiveAlso: Optive Lubricant eye dropsLubricant eye drops | Other | Optive |
Primary outcome
TBUT
Time frame: 14 Days
Tear Film break-up time
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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 Systane Ultra and Optive 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 8 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 was withdrawn before enrolling participants, so there are no results.
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?
TBUT (time frame: 14 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 8 Feb 2012.