Post Menopausal Dry Eye SubjectsPhase 4NCT01105910
Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye
A Phase 4 study testing Systane Ultra Lubricant Eye Drops and Sensitive Eyes Eye Drops (Bausch & Lomb) in people with Post Menopausal Dry Eye Subjects, run by Alcon Research.
Trial summary
To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Menopausal Dry Eye Subjects
- What is being tested?
- Systane Ultra Lubricant Eye Drops and Sensitive Eyes Eye Drops (Bausch & Lomb)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Dec 2010
- Phase
- Phase 4
- 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
- Post-menopausal (menses ceased more than 12 months prior to the start of the study).
- Diagnosed for dry eye
Who cannot join
- History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma.
- Active and severe blepharitis, rosacea and associated ocular sequelae.
- Has any significant eyelid abnormality affecting lid function.
About this study
To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.
- Conditions
- Post Menopausal Dry Eye Subjects
- Being tested
- Systane Ultra Lubricant Eye Drops, Sensitive Eyes Eye Drops (Bausch & Lomb)
- Keywords
- Dry Eye, Post Menopausal 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.
Systane Ultra Lubricant Eye DropsOther
1 to 2 drops in each eye 4 times per day for 30 days
Sensitive Eyes Eye Drops (Bausch & Lomb)Other
1 to 2 drops in each eye 4 times per day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra | Experimental | Systane Ultra Lubricant Eye Drops Receives: Other: Systane Ultra Lubricant Eye Drops |
| Sensitive Eyes | Active comparator | Sensitive Eyes Eye Drops (Bausch \& Lomb) Receives: Other: Sensitive Eyes Eye Drops (Bausch & Lomb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in corneal staining
Measured: 30 days
Secondary outcomes (1)
Patient acceptability / comfort
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Menopausal Dry Eye SubjectsStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 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
- NCT01105910
- Sponsor's protocol ID
- SMA-09-21
- Status last verified
- Jan 2012
- First submitted
- 15 Apr 2010
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
http://www.aaopt.org/efficacy-evaluation-systane-ultra-lubricant-eye-drops-postmenopausal-women-dry-eye
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye
- ClinicalTrials.gov ID
- NCT01105910
- Acronym / sponsor ID
- SMA-09-21
- Conditions
- Post Menopausal Dry Eye Subjects
- Keywords
- Dry Eye, Post Menopausal dry eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- First posted
- 19 Apr 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.
To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra | Experimental | Other: Systane Ultra Lubricant Eye DropsSystane Ultra Lubricant Eye Drops |
| Sensitive Eyes | Active comparator | Other: Sensitive Eyes Eye Drops (Bausch & Lomb)Sensitive Eyes Eye Drops (Bausch \& Lomb) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-menopausal (menses ceased more than 12 months prior to the start of the study).
- Diagnosed for dry eye
Key exclusion criteria (3 listed)
- History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma.
- Active and severe blepharitis, rosacea and associated ocular sequelae.
- Has any significant eyelid abnormality affecting lid function.
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 Ultra Lubricant Eye Drops1 to 2 drops in each eye 4 times per day for 30 days | Other | Systane Ultra |
| Sensitive Eyes Eye Drops (Bausch & Lomb)1 to 2 drops in each eye 4 times per day for 30 days | Other | Sensitive Eyes |
Primary outcome
Reduction in corneal staining
Time frame: 30 days
1 secondary outcome
Patient acceptability / comfort
Time frame: 30 days
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 18 Nov 2016.
- Results publicationhttp://www.aaopt.org/efficacy-evaluation-systane-ultra-lubricant-eye-drops-postmenopausal-women-dry-eye
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 Phase 4 study testing Systane Ultra Lubricant Eye Drops and Sensitive Eyes Eye Drops (Bausch & Lomb) in people with Post Menopausal Dry Eye Subjects, 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 2 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 18 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in corneal staining (time frame: 30 days). 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 NCT01105910, 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 18 Nov 2016.