Dry EyeNCT00756093
Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops
A study testing Systane Ultra Lubricant Eye Drops, Optive Lubricant Eye Drops and Blink Tears in people with Dry Eye, run by Alcon Research at 1 site in United States.
Trial summary
To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients 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, Optive Lubricant Eye Drops and Blink Tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 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 topical ocular drops within 2 hours preceding enrollment
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients
- Conditions
- Dry Eye
- Being tested
- Systane Ultra Lubricant Eye Drops, Optive Lubricant Eye Drops, Blink Tears, GenTeal Moderate 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 one drop each eye one time
Optive Lubricant Eye DropsOther
Optive Lubricant Eye Drops one drop each eye one time
Blink TearsOther
Blink Tears one drop each eye one time
GenTeal Moderate Lubricant Eye DropsOther
GenTeal Moderate Lubricant Eye Drops one drop each eye one time
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra Lubricant Eye Drops | Experimental | Systane Ultra Lubricant Eye Drops 1 drop each one time Receives: Other: Systane Ultra Lubricant Eye Drops |
| Optive Lubricant Eye Drops | Active comparator | Optive Lubricant Eye Drops 1 drop each eye one time Receives: Other: Optive Lubricant Eye Drops |
| Blink Tears | Active comparator | Blink Tears 1 drop each eye one time Receives: Other: Blink Tears |
| GenTeal Moderate Lubricant Eye Drops | Active comparator | GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time Receives: Other: GenTeal Moderate 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 posted19 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2008
- Study completionSep 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
- NCT00756093
- Sponsor's protocol ID
- M-08-10
- Status last verified
- Jan 2012
- First submitted
- 17 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 Blurring Profile Evaluation of Marketed Lubricant Eye Drops
- ClinicalTrials.gov ID
- NCT00756093
- Acronym / sponsor ID
- M-08-10
- 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
- Sep 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 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 and blur profile between four marketed artificial tears in dry eye patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra Lubricant Eye Drops | Experimental | Other: Systane Ultra Lubricant Eye DropsSystane Ultra Lubricant Eye Drops 1 drop each one time |
| Optive Lubricant Eye Drops | Active comparator | Other: Optive Lubricant Eye DropsOptive Lubricant Eye Drops 1 drop each eye one time |
| Blink Tears | Active comparator | Other: Blink TearsBlink Tears 1 drop each eye one time |
| GenTeal Moderate Lubricant Eye Drops | Active comparator | Other: GenTeal Moderate Lubricant Eye DropsGenTeal Moderate Lubricant Eye Drops 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 topical ocular drops within 2 hours 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 one drop each eye one time | Other | Systane Ultra Lubricant Eye Drops |
| Optive Lubricant Eye DropsOptive Lubricant Eye Drops one drop each eye one time | Other | Optive Lubricant Eye Drops |
| Blink TearsBlink Tears one drop each eye one time | Other | Blink Tears |
| GenTeal Moderate Lubricant Eye DropsGenTeal Moderate Lubricant Eye Drops one drop each eye one time | Other | GenTeal Moderate Lubricant Eye Drops |
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, Optive Lubricant Eye Drops and Blink Tears 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.