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Clinical Trials/NCT00796926
NCT00796926CompletedPhase 3

Randomised Controlled Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes

Louis Tong1 site in 1 country30 target enrollmentStarted: July 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Visual Analog Score (VAS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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
  • •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)
  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

Systane Ultra

Experimental

Used four times a day topically to each eye

Intervention: Systane Ultra eyedrops (Drug)

Refresh

Active Comparator

Used four times a day topically to each eye

Intervention: Refresh eye drops (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Corneal Fluorescein Staining Score(6 weeks)
  • Tear Break Up Time (TBUT)(6 weeks)
  • Schirmer I Reading(6 weeks)
  • Meibography Grading(6 weeks)
  • Tear Osmolarity(6 weeks)
  • Superior and Inferior Tear Meniscus Height(6 weeks)

Investigators

Sponsor
Louis Tong
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Louis Tong

Clinician-Scientist, Consultant

Singapore National Eye Centre

Study Sites (1)

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