XerophthalmiaPhase 3NCT00796926
Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
A Phase 3 study testing Systane Ultra eyedrops and Refresh eye drops in people with Xerophthalmia and Blepharitis, run by Louis Tong at 1 site in Singapore.
Trial summary
Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Xerophthalmia, Blepharitis
- What is being tested?
- Systane Ultra eyedrops and Refresh eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2009to Nov 2010
- Phase
- Phase 3
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject age is between 40 and 65 years old.
- Corneal fluorescein staining present in at least one/five sectors of at least one cornea
- At least one question out of 6 questions on dry eye symptom present often or all the time.
- based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry, gritty, red, watery, crusted, stuck in the morning?) Please see appendix 1.
- At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least one eye
- Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of Marx's line in line with Meibomian orifice)
Show all 9Show fewer
- Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain from non-trial topical eye medications for 6 weeks.
- Use of lubricants during the week before recruitment (ranging from 3 times in the week to less than 6 times a day every day).
- Able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3 times over week to less than 6 times a day in all days.
Who cannot join
- Known history of thyroid disorders (diagnosed by physician).
- Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician).
- No ocular surgery within 6 months and LASIK within 1 year.
- Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
- Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
- Anticipated necessity to wear contact lens in the duration of the study.
- Not living in the same household as another participant of the study.
- Any other specified reason as determined by clinical investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes
Read the detailed description
Comparison of efficacy of Systane Ultra and Refresh Tears
- Conditions
- Xerophthalmia, Blepharitis
- Being tested
- Systane Ultra eyedrops, Refresh eye drops
- Medical subject headings
- Xerophthalmia, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane Ultra eyedropsDrug
Also called Systane Ultra, Alcon
Four times a day
Refresh eye dropsDrug
Also called Refresh, Allergan
Four times a day
| Study group | Role | What they receive |
|---|---|---|
| Systane Ultra | Experimental | Used four times a day topically to each eye Receives: Drug: Systane Ultra eyedrops |
| Refresh | Active comparator | Used four times a day topically to each eye Receives: Drug: Refresh eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score (VAS)
Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum
Measured: 6 weeks
Secondary outcomes (6)
Corneal Fluorescein Staining Score
This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any
Measured: 6 weeks
Tear Break Up Time (TBUT)
Measured: 6 weeks
Schirmer I Reading
Measured: 6 weeks
Meibography Grading
Measured: 6 weeks
Tear Osmolarity
This is measured by the TearLab (Ocusense) system
Measured: 6 weeks
Superior and Inferior Tear Meniscus Height
This is determined by anterior segment OCT visante system
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionNov 2010
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 XerophthalmiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Tong
- Sponsor type
- Other government
- Collaborators
- Alcon Research
- Responsible party
- Sponsor-investigator, Louis Tong, Singapore National Eye Centre
- Investigators
- Louis Tong, FRCS, MD, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796926
- Sponsor's protocol ID
- R632/53/2008
- Status last verified
- Oct 2011
- First submitted
- 21 Nov 2008
- Last updated
- 7 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
- ClinicalTrials.gov ID
- NCT00796926
- Acronym / sponsor ID
- R632/53/2008
- Conditions
- Xerophthalmia, Blepharitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Louis TongOther government
- Collaborators
- Alcon Research
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 12 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes
Detailed description
Comparison of efficacy of Systane Ultra and Refresh Tears
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Ultra | Experimental | Drug: Systane Ultra eyedropsUsed four times a day topically to each eye |
| Refresh | Active comparator | Drug: Refresh eye dropsUsed four times a day topically to each eye |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject age is between 40 and 65 years old.
- Corneal fluorescein staining present in at least one/five sectors of at least one cornea
- At least one question out of 6 questions on dry eye symptom present often or all the time.
- based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry, gritty, red, watery, crusted, stuck in the morning?) Please see appendix 1.
- At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least one eye
Key exclusion criteria (8 listed)
- Known history of thyroid disorders (diagnosed by physician).
- Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician).
- No ocular surgery within 6 months and LASIK within 1 year.
- Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
- Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
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 eyedropsAlso: Systane Ultra, AlconFour times a day | Drug | Systane Ultra |
| Refresh eye dropsAlso: Refresh, AllerganFour times a day | Drug | Refresh |
Primary outcome
Visual Analog Score (VAS)
Time frame: 6 weeks
Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum
6 secondary outcomes
Corneal Fluorescein Staining Score
Time frame: 6 weeks
Tear Break Up Time (TBUT)
Time frame: 6 weeks
Schirmer I Reading
Time frame: 6 weeks
Meibography Grading
Time frame: 6 weeks
Tear Osmolarity
Time frame: 6 weeks
Superior and Inferior Tear Meniscus Height
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- 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.
Louis Tong, FRCS, MD principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Systane Ultra eyedrops and Refresh eye drops in people with Xerophthalmia and Blepharitis, run by Louis Tong at 1 site in Singapore.
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 9 inclusion and 8 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 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2011). 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?
Visual Analog Score (VAS) (time frame: 6 weeks). 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 7 Oct 2011.