Dry EyePhase 4NCT01199510
Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
A Phase 4 study of Dry Eye and Cataract Surgery, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA® Lubricating Drops) plus standard of care to standard of care alone, in subjects with a history of intermittent eye irritation or dryness related to environmental factors and scheduled for routine cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Cataract Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jun 2011
- 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
- Patients must be at least 18 years of age
- Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation
Who cannot join
- Patients for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
- Patients cannot have a history of hypersensitivity to any component of FID 112903.
- Patients cannot have previous intraocular or corneal surgery or any planned within 30 days.
- Patients cannot use any ocular medications other than test article and standard of care post-op medications in past 14 days or during study.
- Patients cannot be on chronic systemic corticosteroid or other immunosuppressive therapy.
- Patients cannot have a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative Intraocular pressure >25 millimeters mercury in either eye.
- Patients cannot have a history and/or current evidence of the following: clinically significant corneal scarring, blepharitis or macular pathology in either eye, Herpes zoster or Herpes simplex keratitis.
About this study
The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA® Lubricating Drops) plus standard of care to standard of care alone, in subjects with a history of intermittent eye irritation or dryness related to environmental factors and scheduled for routine cataract surgery.
- Conditions
- Dry Eye, Cataract Surgery
- Being tested
- FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care, Standard of Care
- 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.
FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of careOther
Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively
Standard of CareOther
Post Cataract Surgery Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care plus FID 112903 | Experimental | SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily Receives: Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care |
| Standard of Care only | Active comparator | Post Cataract Standard of Care Regimen Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Comfort
Ocular comfort will be reported by the patient on a questionnaire
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 posted13 Sep 2010 (estimated)
- Study startSep 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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
- NCT01199510
- Sponsor's protocol ID
- SMA-09-05
- Status last verified
- Jan 2012
- First submitted
- 9 Sep 2010
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
http://www.escrs.org/abstracts/details.asp?confid=9&sessid=372&type=free&paperid=14295
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 Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
- ClinicalTrials.gov ID
- NCT01199510
- Acronym / sponsor ID
- SMA-09-05
- Conditions
- Dry Eye, Cataract Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Sep 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.
The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA® Lubricating Drops) plus standard of care to standard of care alone, in subjects with a history of intermittent eye irritation or dryness related to environmental factors and scheduled for routine cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care plus FID 112903 | Experimental | Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of careSYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily |
| Standard of Care only | Active comparator | Other: Standard of CarePost Cataract Standard of Care Regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be at least 18 years of age
- Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation
Key exclusion criteria (7 listed)
- Patients for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
- Patients cannot have a history of hypersensitivity to any component of FID 112903.
- Patients cannot have previous intraocular or corneal surgery or any planned within 30 days.
- Patients cannot use any ocular medications other than test article and standard of care post-op medications in past 14 days or during study.
- Patients cannot be on chronic systemic corticosteroid or other immunosuppressive therapy.
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 |
|---|---|---|
| FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of carePatients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively | Other | Standard of Care plus FID 112903 |
| Standard of CarePost Cataract Surgery Standard of Care | Other | Standard of Care only |
Primary outcome
Ocular Comfort
Time frame: 30 days
Ocular comfort will be reported by the patient on a questionnaire
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.escrs.org/abstracts/details.asp?confid=9&sessid=372&type=free&paperid=14295
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Dry Eye and Cataract Surgery, 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 7 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?
Ocular Comfort (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 NCT01199510, 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.