Blepharitis, Xerophthalmia
Conditions
Brief summary
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
Interventions
DRUGSystane Ultra eyedrops
Four times a day
DRUGRefresh eye drops
Four times a day
Sponsors
Alcon Research
Louis Tong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subject age is between 40 and 65 years old. 2. Corneal fluorescein staining present in at least one/five sectors of at least one cornea 3. 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. 4. At least one of the following: TBUT \<= 5 s or Schirmer I less than 8 mm in at least one eye 5. Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of Marx's line in line with Meibomian orifice) 6. Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain from non-trial topical eye medications for 6 weeks. 7. Use of lubricants during the week before recruitment (ranging from 3 times in the week to less than 6 times a day every day). 8. 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.
Exclusion criteria
1. Known history of thyroid disorders (diagnosed by physician). 2. Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician). 3. No ocular surgery within 6 months and LASIK within 1 year. 4. Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks. 5. Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos. 6. Anticipated necessity to wear contact lens in the duration of the study. 7. Not living in the same household as another participant of the study. 8. Any other specified reason as determined by clinical investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score (VAS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break Up Time (TBUT) | 6 weeks | — |
| Schirmer I Reading | 6 weeks | — |
| Corneal Fluorescein Staining Score | 6 weeks | 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 |
| Tear Osmolarity | 6 weeks | This is measured by the TearLab (Ocusense) system |
| Superior and Inferior Tear Meniscus Height | 6 weeks | This is determined by anterior segment OCT visante system |
| Meibography Grading | 6 weeks | — |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Systane Ultra four times a day for six weeks in each eye | 15 |
| Refresh Four times a day for 6 weeks in each eye | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Refresh | Systane Ultra | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age Continuous | 55.7 years STANDARD_DEVIATION 5.5 | 56.2 years STANDARD_DEVIATION 5.8 | 55.9 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment Singapore | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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
Time frame: 6 weeks
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Ultra | Visual Analog Score (VAS) | 21.55 scores on a scale | Standard Deviation 16.8 |
| Refresh | Visual Analog Score (VAS) | 27.27 scores on a scale | Standard Deviation 15 |
p-value: >0.05t-test, 2 sided
Secondary
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
Time frame: 6 weeks
Secondary
Meibography Grading
Time frame: 6 weeks
Secondary
Schirmer I Reading
Time frame: 6 weeks
Secondary
Superior and Inferior Tear Meniscus Height
This is determined by anterior segment OCT visante system
Time frame: 6 weeks
Secondary
Tear Break Up Time (TBUT)
Time frame: 6 weeks
Secondary
Tear Osmolarity
This is measured by the TearLab (Ocusense) system
Time frame: 6 weeks