Dry EyeNCT01967147
Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects
A study testing Propylene Glycol, 0.6% eye drops and Preservative-free 0.9% Saline solution in people with Dry Eye, run by Alcon Research.
Trial summary
The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating 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% eye drops and Preservative-free 0.9% Saline solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jan 2015
- 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
- Must have all of the following in at least 1 eye at Screening:
- Meibomian Gland Dysfunction (MGD) grading for Expressibility ≤ 2 and Meibum Quality ≤ 2,
- The average of 3 measures of TFBUT ≤ 5 seconds, and
- Unanesthetized Schirmer I test of ≥ 3 mm.
- Must have an Ocular Surface Disease Index (OSDI) Score ≥ 18 at Visit 1 prior to randomization (ie, after 2 weeks of run-in with Preservative-Free 0.9% Saline administered 4 times a day).
- Must have best-corrected visual acuity of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart (letter read method).
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- Physician diagnosis of dry eye at least 6 months prior to Screening visit.
- Willing and able to attend all study visits.
- Must sign a written informed consent form.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Subjects on topical ocular treatments containing benzalkonium chloride (BAK), or other products with known toxicity to the corneal surface, within 30 days of Screening.
- Subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of Screening.
- Use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of Screening.
- Women of childbearing potential are excluded from participating in this study if they met any of the following conditions:
- Currently pregnant, or
- Test positive for pregnancy at Screening visit, or
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- Currently breast feeding, or
- Are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products.
- Has an active ocular allergy.
- Any ocular abnormalities that could adversely affect the safety or efficacy outcome, including eyelid anomalies, corneal disorders, history of herpes simplex, etc.
- Subjects taking any systemic medication known to cause dry eye unless they have been on stable therapy/dosage for at least 30 days prior to Screening and will remain on a stable dosage for the duration of the study.
- History of any ocular or intraocular surgery (including periocular Botox injections), eyelid surgery, keratorefractive procedure, corneal transplant and its variants, or serious ocular trauma within 1 year of Screening.
- Active ocular infection (bacterial, viral or fungal), active inflammation not associated with dry eye such as uveitis, iritis, active blepharitis, active allergic conjunctivitis, etc.
- Subjects with punctal plug insertion or diathermy procedure initiated within 30 days of Screening.
- Any significant illnesses that could be expected to interfere with the study parameters.
- Subjects with active oculodermal rosacea with meibomian gland dysfunction.
- Participation in an investigational drug or device trial within 30 days of Screening.
- Contact lens use within 30 days prior to Screening, or unwilling to avoid contact lens use during the course of the study.
- Unwilling to avoid the use of additional artificial tears/lubricants/gels/rewetting drops (other than the assigned study medication) throughout the course of the study.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Evaluation of Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects With Lipid Deficiency
The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry eye subjects with lipid deficiency.
Read the detailed description
This study consisted of 4 visits conducted during 3 sequential phases: the Run-in Phase (which included a screening visit and run-in period), Treatment Phase I and Treatment Phase II. In Phase I, subjects were randomized to either Systane® Balance or Saline and dosed 4 times a day for 35 days. In Phase II (Day 35-90) subjects continued to dose with their assigned product on an as-needed basis.
- Conditions
- Dry Eye
- Being tested
- Propylene Glycol, 0.6% eye drops, Preservative-free 0.9% Saline solution
- Keywords
- Dry eye, Lipid deficiency, Tear film break-up time
- 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% eye dropsDrug
Also called Systane® Balance
Commercially available eye drops used during Treatment Phase
Preservative-free 0.9% Saline solutionDrug
Commercially available solution used as Run-in (1 drop in each eye 4 times a day for 15 days) and during Treatment Phase
| Study group | Role | What they receive |
|---|---|---|
| Systane Balance | Experimental | Propylene Glycol, 0.6% eye drops, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90). Receives: Drug: Propylene Glycol, 0.6% eye drops |
| Saline | Active comparator | Preservative-Free 0.9% Saline solution, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90). Receives: Drug: Preservative-free 0.9% Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in TFBUT at Day 35
TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 35
Secondary outcomes (4)
Change From Baseline in TOSS Score at Day 35
The TOSS score (a cumulative cornea and conjunctival staining score) was assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface were graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15. A negative change indicates an improvement in dry eye-related staining. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 35
Change From Baseline in OSDI Score at Day 35
The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative change number represents a perceived improvement in ocular health.
Measured: Baseline (Day 0), Day 35
Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35
The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment effectiveness questions (Questions 2-5) using a 0-4 Likert-type scale, where 0=None of the time and 4=All of the time. The IDEEL treatment effectiveness score was calculated as the sum of the responses from Questions 2-5 divided by the number of questions (2-5) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.
Measured: Baseline (Day 0), Day 35
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35
The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment inconvenience questions (Questions 6, 8-10) using a 0-4 Likert-type scale, where 0=All of the time and 4=None of the time. The IDEEL treatment inconvenience score was calculated as the sum of the responses from Questions 6, 8-10 divided by the number of questions (6, 8-10) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.
Measured: Baseline (Day 0), Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Clinical Manager, GCRA, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967147
- Sponsor's protocol ID
- M-13-027
- Status last verified
- Feb 2016
- First submitted
- 18 Oct 2013
- Last updated
- 23 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects With Lipid Deficiency
- ClinicalTrials.gov ID
- NCT01967147
- Acronym / sponsor ID
- M-13-027
- Conditions
- Dry Eye
- Keywords
- Dry eye, Lipid deficiency, Tear film break-up time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Posted 23 Mar 2016
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 is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry eye subjects with lipid deficiency.
Detailed description
This study consisted of 4 visits conducted during 3 sequential phases: the Run-in Phase (which included a screening visit and run-in period), Treatment Phase I and Treatment Phase II. In Phase I, subjects were randomized to either Systane® Balance or Saline and dosed 4 times a day for 35 days. In Phase II (Day 35-90) subjects continued to dose with their assigned product on an as-needed basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Balance | Experimental | Drug: Propylene Glycol, 0.6% eye dropsPropylene Glycol, 0.6% eye drops, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90). |
| Saline | Active comparator | Drug: Preservative-free 0.9% Saline solutionPreservative-Free 0.9% Saline solution, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must have all of the following in at least 1 eye at Screening:
- Must have an Ocular Surface Disease Index (OSDI) Score ≥ 18 at Visit 1 prior to randomization (ie, after 2 weeks of run-in with Preservative-Free 0.9% Saline administered 4 times a day).
- Must have best-corrected visual acuity of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart (letter read method).
- Physician diagnosis of dry eye at least 6 months prior to Screening visit.
- Willing and able to attend all study visits.
Key exclusion criteria (21 listed)
- Subjects on topical ocular treatments containing benzalkonium chloride (BAK), or other products with known toxicity to the corneal surface, within 30 days of Screening.
- Subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of Screening.
- Use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of Screening.
- Women of childbearing potential are excluded from participating in this study if they met any of the following conditions:
- Hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products.
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% eye dropsAlso: Systane® BalanceCommercially available eye drops used during Treatment Phase | Drug | Systane Balance |
| Preservative-free 0.9% Saline solutionCommercially available solution used as Run-in (1 drop in each eye 4 times a day for 15 days) and during Treatment Phase | Drug | Saline |
Primary outcome
Change From Baseline in TFBUT at Day 35
Time frame: Baseline (Day 0), Day 35
TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.
4 secondary outcomes
Change From Baseline in TOSS Score at Day 35
Time frame: Baseline (Day 0), Day 35
Change From Baseline in OSDI Score at Day 35
Time frame: Baseline (Day 0), Day 35
Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35
Time frame: Baseline (Day 0), Day 35
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35
Time frame: Baseline (Day 0), Day 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- 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.
Senior Clinical Manager, GCRA study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Propylene Glycol, 0.6% eye drops and Preservative-free 0.9% Saline solution 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 10 inclusion and 21 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 23 Mar 2016. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2016). 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?
Change From Baseline in TFBUT at Day 35 (time frame: Baseline (Day 0), Day 35). 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 23 Mar 2016.