Dry EyeNCT00748865
Acute Comfort and Blur of Systane Ultra and Systane
A study testing Systane Ultra Lubricant Eye Drops and Systane Lubricant Eye Drops in people with Dry Eye, run by Alcon Research at 1 site in United States.
Trial summary
To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Systane Ultra Lubricant Eye Drops and Systane Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Documented diagnosis of dry eye
Who cannot join
- Use of contact lens within 7 days preceding enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Location
Fort Worth, Texas, 76134
About this study
To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.
- Conditions
- Dry Eye
- Being tested
- Systane Ultra Lubricant Eye Drops, Systane Lubricant Eye Drops
- Keywords
- Dry Eye, Artificial Tears
- 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
Systane Ultra Lubricant Eye Drops 1 drop each eye one time
Systane Lubricant Eye DropsOther
Systane Lubricant Eye Drops 1 drop each eye one time
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra | Experimental | Systane Ultra 1 drop each eye one time Receives: Other: Systane Ultra Lubricant Eye Drops |
| Systane | Active comparator | Systane 1 drop each eye one time Receives: Other: Systane Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop Comfort
Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,
Measured: once upon instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT00748865
- Sponsor's protocol ID
- M-08-09
- Status last verified
- Jan 2012
- First submitted
- 5 Sep 2008
- Last updated
- 2 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- 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
- Acute Comfort and Blur of Systane Ultra and Systane
- ClinicalTrials.gov ID
- NCT00748865
- Acronym / sponsor ID
- M-08-09
- Conditions
- Dry Eye
- Keywords
- Dry Eye, Artificial Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Posted 11 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra | Experimental | Other: Systane Ultra Lubricant Eye DropsSystane Ultra 1 drop each eye one time |
| Systane | Active comparator | Other: Systane Lubricant Eye DropsSystane 1 drop each eye one time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documented diagnosis of dry eye
Key exclusion criteria (1 listed)
- Use of contact lens within 7 days preceding enrollment
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 DropsSystane Ultra Lubricant Eye Drops 1 drop each eye one time | Other | Systane Ultra |
| Systane Lubricant Eye DropsSystane Lubricant Eye Drops 1 drop each eye one time | Other | Systane |
Primary outcome
Drop Comfort
Time frame: once upon instillation
Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Ultra Lubricant Eye Drops and Systane Lubricant Eye Drops in people with Dry Eye, run by Alcon Research at 1 site in United States.
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 2 Feb 2012. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Drop Comfort (time frame: once upon instillation). 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.