Dry EyeNCT00348517
Safety/Efficacy of Systane Free vs Refresh Liquigel
A study testing Systane Free Lubricant Eye Drops and Refresh Liquigel Lubricant Eye Drops in people with Dry Eye, run by Alcon Research.
Trial summary
The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of 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 Free Lubricant Eye Drops and Refresh Liquigel Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Nov 2006
- Phase
- Interventional
- 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
- >/= 3 corneal staining score using NEI scoring system.
- Need artificial tears at least some of the time.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- History or evidence of ocular or intraocular surgery in either eye within the past six months.
- History of intolerance or hypersensitivity to any component of the study medication.
- Use of Restasis within 30 days of Visit 1.
- Participation in an investigational drug or device study within 30 days of entering this study.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: An Evaluation of the Safety and Efficacy of Systane Free FID 105783
The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.
- Conditions
- Dry Eye
- Being tested
- Systane Free Lubricant Eye Drops, Refresh Liquigel 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 Free Lubricant Eye DropsOther
1-2 drops per eye four times per day for 42 days
Refresh Liquigel Lubricant Eye DropsOther
1-2 drops per eye four times per day for 42 days
| Study group | Role | What they receive |
|---|---|---|
| Systane | Experimental | Not described Receives: Other: Systane Free Lubricant Eye Drops |
| Refresh | Active comparator | Not described Receives: Other: Refresh Liquigel Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal staining at Day 28 from baseline (Day 0)
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionNov 2006
- Study completionNov 2006
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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
- NCT00348517
- Sponsor's protocol ID
- C-05-45
- Status last verified
- Mar 2012
- First submitted
- 30 Jun 2006
- Last updated
- 5 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Efficacy of Systane Free FID 105783
- ClinicalTrials.gov ID
- NCT00348517
- Acronym / sponsor ID
- C-05-45
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006
- First posted
- 4 Jul 2006 (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.
The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane | Experimental | Other: Systane Free Lubricant Eye Drops |
| Refresh | Active comparator | Other: Refresh Liquigel 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 (3 listed)
- >/= 3 corneal staining score using NEI scoring system.
- Need artificial tears at least some of the time.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- History or evidence of ocular or intraocular surgery in either eye within the past six months.
- History of intolerance or hypersensitivity to any component of the study medication.
- Use of Restasis within 30 days of Visit 1.
- Participation in an investigational drug or device study within 30 days of entering this study.
- Other protocol-defined exclusion criteria may apply.
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 Free Lubricant Eye Drops1-2 drops per eye four times per day for 42 days | Other | Systane |
| Refresh Liquigel Lubricant Eye Drops1-2 drops per eye four times per day for 42 days | Other | Refresh |
Primary outcome
Change in corneal staining at Day 28 from baseline (Day 0)
Time frame: Day 28
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 5 Mar 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 study testing Systane Free Lubricant Eye Drops and Refresh Liquigel 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 3 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 5 Mar 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?
Change in corneal staining at Day 28 from baseline (Day 0) (time frame: Day 28). 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 5 Mar 2012.