Dry EyeNCT00769665
A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.
An observational study of Dry Eye, run by Alcon Research.
Trial summary
To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a currently marketed contact lens rewetting drop will be included as a control. 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 Ultra and Sensitive Eyes Rewetting Drops
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Jan 2009
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- Participants must be between 18 and 65 years of age.
- Provide written Informed Consent.
- Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality, or a Rigid Gas Permeable (RGP) contact Lens
- Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
- Sodium fluorescein (NaFl) corneal staining score sum of < 2 in both eyes (NEI scoring system).
- Must be willing to maintain pre-enrollment systemic medication regimens during the study.
- Must be available for study visits and to fill out study questionnaires.
Who cannot join
- Has modified their systemic medications within 30 days prior to enrollment.
- Has a history of allergy to any study product ingredients
- Is unwilling or unable to meet the study visit timeline.
- Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
- Is currently using any topical eye medications (not including rewetting drops, artificial tear products or Restasis).
About this study
To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a currently marketed contact lens rewetting drop will be included as a control.
- Conditions
- Dry Eye
- Being tested
- Systane Ultra, Sensitive Eyes Rewetting Drops
- Keywords
- Dry Eye, re-wetting 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 UltraOther
Re-wetting ocular eye drop
Sensitive Eyes Rewetting DropsOther
Re-wetting ocular eye drop
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra | Systane Ultra Receives: Other: Systane Ultra | |
| Sensitive Eyes | Sensitive Eyes Receives: Other: Sensitive Eyes Rewetting Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events and Visual Acuity
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2009
- Study completionJan 2009
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 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
- NCT00769665
- Sponsor's protocol ID
- SMA-08-15
- Status last verified
- Jan 2012
- First submitted
- 7 Oct 2008
- 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
- A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.
- ClinicalTrials.gov ID
- NCT00769665
- Acronym / sponsor ID
- SMA-08-15
- Conditions
- Dry Eye
- Keywords
- Dry Eye, re-wetting drops
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 9 Oct 2008 (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.
To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a currently marketed contact lens rewetting drop will be included as a control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra | – | Other: Systane UltraSystane Ultra |
| Sensitive Eyes | – | Other: Sensitive Eyes Rewetting DropsSensitive Eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (7 listed)
- Participants must be between 18 and 65 years of age.
- Provide written Informed Consent.
- Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality, or a Rigid Gas Permeable (RGP) contact Lens
- Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
- Sodium fluorescein (NaFl) corneal staining score sum of < 2 in both eyes (NEI scoring system).
Key exclusion criteria (5 listed)
- Has modified their systemic medications within 30 days prior to enrollment.
- Has a history of allergy to any study product ingredients
- Is unwilling or unable to meet the study visit timeline.
- Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
- Is currently using any topical eye medications (not including rewetting drops, artificial tear products or Restasis).
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 UltraRe-wetting ocular eye drop | Other | Systane Ultra |
| Sensitive Eyes Rewetting DropsRe-wetting ocular eye drop | Other | Sensitive Eyes |
Primary outcome
Adverse Events and Visual Acuity
Time frame: 2 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?
An observational study of 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 7 inclusion and 5 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?
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?
Adverse Events and Visual Acuity (time frame: 2 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.