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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00796926
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : August 12, 2011
Last Update Posted : October 7, 2011
Alcon Research
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

Brief Summary:
Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes

Condition or disease Intervention/treatment Phase
Xerophthalmia Blepharitis Drug: Systane Ultra eyedrops Drug: Refresh eye drops Phase 3

Detailed Description:
Comparison of efficacy of Systane Ultra and Refresh Tears

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Systane

Arm Intervention/treatment
Experimental: Systane Ultra
Used four times a day topically to each eye
Drug: Systane Ultra eyedrops
Four times a day
Other Name: Systane Ultra, Alcon

Active Comparator: Refresh
Used four times a day topically to each eye
Drug: Refresh eye drops
Four times a day
Other Name: Refresh, Allergan

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00796926

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Singapore National Eye Center
Singapore, Singapore, 168751
Sponsors and Collaborators
Louis Tong
Alcon Research
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Principal Investigator: Louis Tong, FRCS, MD Singapore National Eye Centre

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Responsible Party: Louis Tong, Clinician-Scientist, Consultant, Singapore National Eye Centre Identifier: NCT00796926     History of Changes
Other Study ID Numbers: R632/53/2008
First Posted: November 24, 2008    Key Record Dates
Results First Posted: August 12, 2011
Last Update Posted: October 7, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Eyelid Diseases
Eye Diseases
Conjunctival Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions