Dry EyeNCT01160133
To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops
A study testing Systane and Refresh Tears in people with Dry Eye, run by Alcon Research at 1 site in India.
Trial summary
This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study. 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 and Refresh Tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2010to Jun 2011
- 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
- Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
- A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
- A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.
Who cannot join
- A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
- Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
- A history of intolerance or hypersensitivity to any component of the study medications.
Trial locations and contacts
1 site in 1 country.
About this study
This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.
- Conditions
- Dry Eye
- Being tested
- Systane, Refresh Tears
- Keywords
- Systane, Refresh Tears, Dry Eye, Moderate to Severe Dry Eye
- 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.
SystaneOther
Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)
Refresh TearsOther
Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)
| Study group | Role | What they receive |
|---|---|---|
| Systane | Experimental | Systane Lubricant Eye Drops Receives: Other: Systane |
| Refresh Tears | Experimental | Refresh Tears Lubricant Eye Drops Receives: Other: Refresh Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.
This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.
Measured: Baseline to visit 3 (Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionJun 2011
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
- 78 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
- NCT01160133
- Sponsor's protocol ID
- SMA-09-67
- Status last verified
- Jan 2012
- First submitted
- 9 Jul 2010
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops
- ClinicalTrials.gov ID
- NCT01160133
- Acronym / sponsor ID
- SMA-09-67
- Conditions
- Dry Eye
- Keywords
- Systane, Refresh Tears, Dry Eye, Moderate to Severe Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 Jul 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.
This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.
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: SystaneSystane Lubricant Eye Drops |
| Refresh Tears | Experimental | Other: Refresh TearsRefresh Tears 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)
- Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
- A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
- A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.
Key exclusion criteria (3 listed)
- A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
- Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
- A history of intolerance or hypersensitivity to any component of the study medications.
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 |
|---|---|---|
| SystaneSystane Lubricant Eye Drops (1-2 drops in each eye, four times per day) | Other | Systane |
| Refresh TearsRefresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day) | Other | Refresh Tears |
Primary outcome
To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.
Time frame: Baseline to visit 3 (Day 42)
This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.
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 10 Apr 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.
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 and Refresh Tears in people with Dry Eye, run by Alcon Research at 1 site in India.
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 3 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 10 Apr 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 India. 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?
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?
To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye. (time frame: Baseline to visit 3 (Day 42)). 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 10 Apr 2012.