Dry EyePhase 4NCT00781092
A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes
A Phase 4 study testing Systane Ultra and Bausch and Lomb Sensitive Eyes in people with Dry Eye, run by Durrie Vision.
Trial summary
The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Systane Ultra and Bausch and Lomb Sensitive Eyes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Mar 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be a suitable candidate for FDA Approved LASIK.
- Subjects must have a stable refraction as documented by previous clinical records.
- Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery.
- Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery.
- Subjects must be at least 18 years of age.
- Subjects must be willing and able to return for scheduled follow up examinations each day after surgery at the specified time.
- Subjects must sign and be given a copy of the written Informed Consent form.
Who cannot join
- Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
- Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
- Subjects with clinically significant anterior segment pathology, including clinically significant cataracts, corneal scarring or neovascularization in either eye.
- Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
- Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or uncontrolled diabetes.
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- Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>25 mm Hg in either eye.
- Subjects with macular pathology in either eye.
- Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
- Subjects with known sensitivity to planned study concomitant medications.
- Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
- Use of ocular drugs, other than study medications, during the study and within 30 days prior to study entry or any other ocular medication.
About this study
The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.
Read the detailed description
This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ Excimer Laser System. Post operative questionnaires regarding the use of the drops will be compared. Tear osmolarity and tear breakup time will be evaluated using Tear Lab and OQAS II.
- Conditions
- Dry Eye
- Being tested
- Systane Ultra, Bausch and Lomb Sensitive Eyes
- Keywords
- Dry Eyes, LASIK, Laser Vision Correction
- 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 UltraOther
Also called Natural Tears
Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative
Bausch and Lomb Sensitive EyesOther
Also called Saline Solution
Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Systane Ultra Receives: Other: Systane Ultra |
| 2 | Active comparator | Bausch and Lomb Sensitive Eyes Receives: Other: Bausch and Lomb Sensitive Eyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear osmolarity
Measured: 2 week, 1 month
Secondary outcomes (1)
Tear Break Up Time
Measured: 2 week, 1 month post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durrie Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Daniel S. Durrie, MD, Durrie Vision
- Investigators
- Daniel S. Durrie, MD, Principal investigator, Durrie Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781092
- Sponsor's protocol ID
- SUSE-01
- Status last verified
- Sep 2012
- First submitted
- 27 Oct 2008
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes
- ClinicalTrials.gov ID
- NCT00781092
- Acronym / sponsor ID
- SUSE-01
- Conditions
- Dry Eye
- Keywords
- Dry Eyes, LASIK, Laser Vision Correction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Durrie VisionUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Oct 2008 (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 primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.
Detailed description
This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ Excimer Laser System. Post operative questionnaires regarding the use of the drops will be compared. Tear osmolarity and tear breakup time will be evaluated using Tear Lab and OQAS II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Systane UltraSystane Ultra |
| 2 | Active comparator | Other: Bausch and Lomb Sensitive EyesBausch and Lomb Sensitive Eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be a suitable candidate for FDA Approved LASIK.
- Subjects must have a stable refraction as documented by previous clinical records.
- Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery.
- Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery.
- Subjects must be at least 18 years of age.
Key exclusion criteria (12 listed)
- Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
- Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
- Subjects with clinically significant anterior segment pathology, including clinically significant cataracts, corneal scarring or neovascularization in either eye.
- Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
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 UltraAlso: Natural TearsOphthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative | Other | 1 |
| Bausch and Lomb Sensitive EyesAlso: Saline SolutionOphthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK | Other | 2 |
Primary outcome
Tear osmolarity
Time frame: 2 week, 1 month
1 secondary outcome
Tear Break Up Time
Time frame: 2 week, 1 month post op
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 20 Sep 2012.
- Durrie Vision ResearchLink provided by the sponsor.
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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.
Daniel S. Durrie, MD principal investigator
Durrie Vision
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Systane Ultra and Bausch and Lomb Sensitive Eyes in people with Dry Eye, run by Durrie Vision.
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 7 inclusion and 12 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 20 Sep 2012. 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?
Tear osmolarity (time frame: 2 week, 1 month). 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 20 Sep 2012.