Dry Eye SyndromeNCT01863368
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
A study testing Preservative-free saline solution eyedrops, Systane® ULTRA lubricant eyedrops and OPTIVE® lubricating eyedrops in people with Dry Eye Syndrome, run by Alcon Research.
Trial summary
The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Preservative-free saline solution eyedrops, Systane® ULTRA lubricant eyedrops and OPTIVE® lubricating eyedrops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jun 2014
- 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
- Willing and able to attend all study visits.
- Diagnosis of dry eye, as specified in protocol.
- Uses artificial tears, as specified in protocol.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Poor visual acuity, as specified in protocol.
- Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
- Any hypersensitivity or allergy to the investigational products or ingredients.
- Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
- Contact lens use within 2 weeks of Screening Visit.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.
Read the detailed description
Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.
- Conditions
- Dry Eye Syndrome
- Being tested
- Preservative-free saline solution eyedrops, Systane® ULTRA lubricant eyedrops, OPTIVE® lubricating eyedrops
- Keywords
- Dry eye syndrome, Systane Ultra, Optive, Ocular Surface Staining, OSDI, 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.
Preservative-free saline solution eyedropsOther
1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.
Systane® ULTRA lubricant eyedropsOther
OPTIVE® lubricating eyedropsOther
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra | Experimental | Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). Receives: Other: Preservative-free saline solution eyedrops; Other: Systane® ULTRA lubricant eyedrops |
| Optive | Active comparator | OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). Receives: Other: Preservative-free saline solution eyedrops; Other: OPTIVE® lubricating eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 35
Secondary outcomes (3)
Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)
The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.
Measured: Day 35
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Measured: Day 35
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies 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
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Burmaster, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863368
- Sponsor's protocol ID
- M-12-040
- Status last verified
- Jul 2015
- First submitted
- 23 May 2013
- Last updated
- 4 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Labetoulle M, Messmer EM, Pisella PJ, Ogundele A, Baudouin C. Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye. Br J Ophthalmol. 2017 Apr;101(4):487-492. doi: 10.1136/bjophthalmol-2016-308608. Epub 2016 Jul 15.
PubMed 27422973
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
- ClinicalTrials.gov ID
- NCT01863368
- Acronym / sponsor ID
- M-12-040
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye syndrome, Systane Ultra, Optive, Ocular Surface Staining, OSDI, Eye drops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 May 2013 (estimated)
- Results
- Posted 10 Jul 2015
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 compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.
Detailed description
Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra | Experimental | Other: Preservative-free saline solution eyedrops, Other: Systane® ULTRA lubricant eyedropsSystane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). |
| Optive | Active comparator | Other: Preservative-free saline solution eyedrops, Other: OPTIVE® lubricating eyedropsOPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to attend all study visits.
- Diagnosis of dry eye, as specified in protocol.
- Uses artificial tears, as specified in protocol.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Poor visual acuity, as specified in protocol.
- Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
- Any hypersensitivity or allergy to the investigational products or ingredients.
- Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
- Contact lens use within 2 weeks of Screening Visit.
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 |
|---|---|---|
| Preservative-free saline solution eyedrops1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II. | Other | Optive, Systane Ultra |
| Systane® ULTRA lubricant eyedrops | Other | Systane Ultra |
| OPTIVE® lubricating eyedrops | Other | Optive |
Primary outcome
Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
Time frame: Baseline, Day 35
The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.
3 secondary outcomes
Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)
Time frame: Day 35
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)
Time frame: Day 35
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)
Time frame: Day 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27422973Labetoulle M, Messmer EM, Pisella PJ, Ogundele A, Baudouin C. Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye. Br J Ophthalmol. 2017 Apr;101(4):487-492. doi: 10.1136/bjophthalmol-2016-308608. Epub 2016 Jul 15.
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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.
Steve Burmaster study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Preservative-free saline solution eyedrops, Systane® ULTRA lubricant eyedrops and OPTIVE® lubricating eyedrops in people with Dry Eye Syndrome, 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 4 inclusion and 6 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 4 Aug 2015. 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 10 Jul 2015). 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 Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) (time frame: Baseline, Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863368, which also lists 1 linked publication.
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 4 Aug 2015.