Clinical trial NCT00796926: Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
Official title: Randomised Controlled Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Xerophthalmia
Blepharitis
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
Collaborators: name: Alcon Research
First posted: 2008-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Score (VAS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Corneal Fluorescein Staining Score
timeFrame: 6 weeks
measure: Tear Break Up Time (TBUT)
timeFrame: 6 weeks
measure: Schirmer I Reading
timeFrame: 6 weeks
measure: Meibography Grading
timeFrame: 6 weeks
measure: Tear Osmolarity
timeFrame: 6 weeks
measure: Superior and Inferior Tear Meniscus Height
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Center
Study officials:
affiliation: Singapore National Eye Centre
name: Louis Tong, FRCS, MD
role: PRINCIPAL_INVESTIGATOR
References: