Dry EyeNCT00673764
The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance
A study testing Systane Ultra Lubricant Eye Drops and Optive Lubricant Eye Drops in people with Dry Eye, run by Alcon Research at 1 site in United States.
Trial summary
To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Systane Ultra Lubricant Eye Drops and Optive Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented diagnosis of dry eye
- Must not have worn contact lenses for 12 hours prior to Day 1
Who cannot join
- Age related
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye
- Conditions
- Dry Eye
- Being tested
- Systane Ultra Lubricant Eye Drops, Optive 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 Ultra Lubricant Eye DropsOther
Systane Ultra Lubricant Eye Drops 1 drop each eye one time
Optive Lubricant Eye DropsOther
Optive Lubricant Eye Drops 1 drop each eye one time
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra | Experimental | Systane Ultra Lubricant Eye Drops Receives: Other: Systane Ultra Lubricant Eye Drops |
| Optive | Active comparator | Optive Lubricant Eye Drops Receives: Other: Optive Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time at Best Corrected Visual Acuity
Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.
Measured: 15 minutes, 45 minutes, and 90 minutes post-dose
Secondary outcomes (1)
Functional Blink Rate Time (Time Between Blinks)
Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.
Measured: 15 minutes, 45 minutes, and 90 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 posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJun 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT00673764
- Sponsor's protocol ID
- C-07-24
- Status last verified
- Jan 2012
- First submitted
- 2 May 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
- The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance
- ClinicalTrials.gov ID
- NCT00673764
- Acronym / sponsor ID
- C-07-24
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 10 Feb 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 the effect of 2 different lubricant eye drops on visual function of patients with dry eye
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra | Experimental | Other: Systane Ultra Lubricant Eye DropsSystane Ultra Lubricant Eye Drops |
| Optive | Active comparator | Other: Optive Lubricant Eye DropsOptive Lubricant Eye Drops |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Documented diagnosis of dry eye
- Must not have worn contact lenses for 12 hours prior to Day 1
Key exclusion criteria (1 listed)
- Age related
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 |
| Optive Lubricant Eye DropsOptive Lubricant Eye Drops 1 drop each eye one time | Other | Optive |
Primary outcome
Time at Best Corrected Visual Acuity
Time frame: 15 minutes, 45 minutes, and 90 minutes post-dose
Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.
1 secondary outcome
Functional Blink Rate Time (Time Between Blinks)
Time frame: 15 minutes, 45 minutes, and 90 minutes post-dose
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 Optive 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 2 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 10 Feb 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?
Time at Best Corrected Visual Acuity (time frame: 15 minutes, 45 minutes, and 90 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.