Dry EyePhase 4NCT01051804
Evaluation of the Repeated Usage of Systane Ultra Eyedrop
A Phase 4 study testing Systane Ultra and Optive lubricant Eye Drops in people with Dry Eye, run by Alcon Research.
Trial summary
Comparison of two contact lens solutions. 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 and Optive lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jul 2010
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or more.
- Non contact lens wearer.
- Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:
- Score ≥13 for OSDI Questionnaire total score; AND
- Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
- Best visual acuity of 6/9 or better in each eye.
- Willingness to adhere to the instructions set in the clinical protocol.
- Signature of the subject informed consent form.
Who cannot join
- Use of systemic medication which might produce dry eye side effects.
- Systemic disease which might produce dry eye side effects.
- Active ocular infection.
- Use of ocular medication.
- Significant ocular anomaly.
- Previous ocular surgery
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- Previous use of Restasis
- Any medical condition that might be prejudicial to the study.
- The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
- The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
- The subject, based on their knowledge, must NOT have diabetes.
About this study
Comparison of two contact lens solutions.
- Conditions
- Dry Eye
- Being tested
- Systane Ultra, Optive lubricant Eye Drops
- Keywords
- Dry eye, Visual Performance
- 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
Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
Optive lubricant Eye DropsOther
Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra | Experimental | Systane Ultra Lubricant Eye Drops Receives: Other: Systane Ultra |
| 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.
Improvement in objective vision
Measured: 4 weeks
Secondary outcomes (1)
Measurement of tear film evaporation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 57 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
- NCT01051804
- Sponsor's protocol ID
- SMA-09-33
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2010
- Last updated
- 2 Feb 2012
- Results posted
- No
- 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
- Evaluation of the Repeated Usage of Systane Ultra Eyedrop
- ClinicalTrials.gov ID
- NCT01051804
- Acronym / sponsor ID
- SMA-09-33
- Conditions
- Dry Eye
- Keywords
- Dry eye, Visual Performance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- First posted
- 20 Jan 2010 (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.
Comparison of two contact lens solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra | Experimental | Other: Systane UltraSystane Ultra Lubricant Eye Drops |
| Optive | Active comparator | Other: Optive lubricant Eye DropsOptive Lubricant Eye Drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or more.
- Non contact lens wearer.
- Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:
- Best visual acuity of 6/9 or better in each eye.
- Willingness to adhere to the instructions set in the clinical protocol.
Key exclusion criteria (11 listed)
- Use of systemic medication which might produce dry eye side effects.
- Systemic disease which might produce dry eye side effects.
- Active ocular infection.
- Use of ocular medication.
- Significant ocular anomaly.
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 UltraSystane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks | Other | Systane Ultra |
| Optive lubricant Eye DropsOptive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks | Other | Optive |
Primary outcome
Improvement in objective vision
Time frame: 4 weeks
1 secondary outcome
Measurement of tear film evaporation
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 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 Phase 4 study testing Systane Ultra 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 8 inclusion and 11 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in objective vision (time frame: 4 weeks). 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.