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OpenTrials
Completed

NCT Number: NCT00796926

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

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Singapore National Eye Center

Singapore, 168751

About this study

Comparison of efficacy of Systane Ultra and Refresh Tears

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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)
  • 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.

Treatment and study plan

Systane Ultra eyedrops

Drug

Four times a day

Other names: Systane Ultra, Alcon

Refresh eye drops

Drug

Four times a day

Other names: Refresh, Allergan

Primary outcomes

  1. 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

  1. Corneal Fluorescein Staining Score

    Time frame: 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

  2. Tear Break Up Time (TBUT)

    Time frame: 6 weeks

  3. Schirmer I Reading

    Time frame: 6 weeks

  4. Meibography Grading

    Time frame: 6 weeks

  5. Tear Osmolarity

    Time frame: 6 weeks

    This is measured by the TearLab (Ocusense) system

  6. Superior and Inferior Tear Meniscus Height

    Time frame: 6 weeks

    This is determined by anterior segment OCT visante system

Sponsors and collaborators

Lead sponsor

Louis Tong

Other Gov

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 24, 2008
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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