Dry EyeNCT00568386
Acute Comfort and Blur of Systane and Optive
A study testing Systane Lubricant Eye Drops and Optive Lubricant Eye Drops in people with Dry Eye, run by Alcon Research.
Trial summary
To evaluate drop comfort, acceptability, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population. 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 Lubricant Eye Drops and Optive Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Dec 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, normal eyes OR documented diagnosis of dry eye
Who cannot join
- Must not have worn contact lenses for 7 days preceding enrollment
About this study
Official title: Acute Comfort and Blurring Profile Evaluation Comparing Systane Lubricant Eye Drops to Optive Lubricant Eye Drops
To evaluate drop comfort, acceptability, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population.
- Conditions
- Dry Eye
- Being tested
- Systane Lubricant Eye Drops, Optive Lubricant Eye Drops
- Keywords
- Dry eye
- 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 Lubricant Eye DropsOther
Systane Lubricant Eye Drops 1 drop each eye once time
Optive Lubricant Eye DropsOther
Optive Lubricant Eye Drops 1 drop each eye one time
| Study group | Role | What they receive |
|---|---|---|
| Systane Lubricant Eye Drops | Experimental | Systane Lubricant Eye Drops 1 drop in each eye one time Receives: Other: Systane Lubricant Eye Drops |
| Optive Lubricant Eye Drops | Active comparator | Optive Lubricant Eye Drops 1 drop each one time Receives: Other: Optive Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Blur
Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.
Measured: 3 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startNov 2007
- Study completionDec 2007
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
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Christensen, Principal investigator, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568386
- Sponsor's protocol ID
- M-07-02
- Status last verified
- Jan 2012
- First submitted
- 5 Dec 2007
- 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 Blurring Profile Evaluation Comparing Systane Lubricant Eye Drops to Optive Lubricant Eye Drops
- ClinicalTrials.gov ID
- NCT00568386
- Acronym / sponsor ID
- M-07-02
- Conditions
- Dry Eye
- Keywords
- Dry eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Posted 10 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 blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Lubricant Eye Drops | Experimental | Other: Systane Lubricant Eye DropsSystane Lubricant Eye Drops 1 drop in each eye one time |
| Optive Lubricant Eye Drops | Active comparator | Other: Optive Lubricant Eye DropsOptive Lubricant Eye Drops 1 drop each one time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, normal eyes OR documented diagnosis of dry eye
Key exclusion criteria (1 listed)
- Must not have worn contact lenses for 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 Lubricant Eye DropsSystane Lubricant Eye Drops 1 drop each eye once time | Other | Systane Lubricant Eye Drops |
| Optive Lubricant Eye DropsOptive Lubricant Eye Drops 1 drop each eye one time | Other | Optive Lubricant Eye Drops |
Primary outcome
Visual Blur
Time frame: 3 minutes post dose
Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.
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.
Mike Christensen principal investigator
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Systane Lubricant Eye Drops and Optive 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 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.
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 10 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?
Visual Blur (time frame: 3 minutes post dose). 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.