Dry EyeNCT01718028
The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects
A study testing Propylene glycol 0.6% ocular emulsion and Sodium chloride 0.9% saline solution in people with Dry Eye, run by Alcon Research at 1 site in Argentina.
Trial summary
The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency. 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?
- Propylene glycol 0.6% ocular emulsion and Sodium chloride 0.9% saline solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteArgentina
- Study dates
- Sep 2012to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Read, sign, and date an information consent;
- Willing and able to follow instructions and maintain the appointment schedule;
- Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1;
- Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
- Meet protocol-specified criteria for dry eye at Visit 1;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months;
- Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs);
- History of intolerance or hypersensitivity to any component of the study medications;
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
- Use of any concomitant topical ocular medications during the study period;
- Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
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- Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation;
- Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
- Participation in an investigational drug or device study within 30 days of entering this study;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of SYSTANE® BALANCE on Non-Invasive Tear Film Break Up Time (NITFBUT) in Dry Eye Subjects With Lipid Deficiency Following 30 Days of Use
The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency.
- Conditions
- Dry Eye
- Being tested
- Propylene glycol 0.6% ocular emulsion, Sodium chloride 0.9% saline solution
- Keywords
- Systane BALANCE, Dry eye, lipid deficiency, NITFBUT
- 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.
Propylene glycol 0.6% ocular emulsionOther
Also called SYSTANE® BALANCE
Sodium chloride 0.9% saline solutionOther
Also called LARMABAK®
| Study group | Role | What they receive |
|---|---|---|
| SYSTANE® BALANCE | Experimental | Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days Receives: Other: Propylene glycol 0.6% ocular emulsion |
| LARMABAK® | Active comparator | Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days Receives: Other: Sodium chloride 0.9% saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in NITFBUT at Day 30
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
Measured: Baseline (Day 0), Day 30
Secondary outcomes (3)
Mean Change From Baseline in NITFBUT at Day 14
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
Measured: Baseline (Day 0), Day 14
Mean NITFBUT by Visit
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.
Measured: Baseline (Day 0), Day 14, Day 30
Percent Change From Baseline in NITFBUT by Visit
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.
Measured: Baseline (Day 0), Day 14, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 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
- NCT01718028
- Sponsor's protocol ID
- RDG-11-262
- Status last verified
- Nov 2013
- First submitted
- 29 Oct 2012
- Last updated
- 6 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of SYSTANE® BALANCE on Non-Invasive Tear Film Break Up Time (NITFBUT) in Dry Eye Subjects With Lipid Deficiency Following 30 Days of Use
- ClinicalTrials.gov ID
- NCT01718028
- Acronym / sponsor ID
- RDG-11-262
- Conditions
- Dry Eye
- Keywords
- Systane BALANCE, Dry eye, lipid deficiency, NITFBUT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Posted 6 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYSTANE® BALANCE | Experimental | Other: Propylene glycol 0.6% ocular emulsionPropylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days |
| LARMABAK® | Active comparator | Other: Sodium chloride 0.9% saline solutionSodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Read, sign, and date an information consent;
- Willing and able to follow instructions and maintain the appointment schedule;
- Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1;
- Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
- Meet protocol-specified criteria for dry eye at Visit 1;
Key exclusion criteria (10 listed)
- History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months;
- Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs);
- History of intolerance or hypersensitivity to any component of the study medications;
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
- Use of any concomitant topical ocular medications during the study period;
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 |
|---|---|---|
| Propylene glycol 0.6% ocular emulsionAlso: SYSTANE® BALANCE | Other | SYSTANE® BALANCE |
| Sodium chloride 0.9% saline solutionAlso: LARMABAK® | Other | LARMABAK® |
Primary outcome
Mean Change From Baseline in NITFBUT at Day 30
Time frame: Baseline (Day 0), Day 30
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
3 secondary outcomes
Mean Change From Baseline in NITFBUT at Day 14
Time frame: Baseline (Day 0), Day 14
Mean NITFBUT by Visit
Time frame: Baseline (Day 0), Day 14, Day 30
Percent Change From Baseline in NITFBUT by Visit
Time frame: Baseline (Day 0), Day 14, Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- 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 Propylene glycol 0.6% ocular emulsion and Sodium chloride 0.9% saline solution in people with Dry Eye, run by Alcon Research at 1 site in Argentina.
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 6 inclusion and 10 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 6 Jan 2014. 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 Argentina. 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 6 Jan 2014). 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?
Mean Change From Baseline in NITFBUT at Day 30 (time frame: Baseline (Day 0), Day 30). 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 6 Jan 2014.