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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00796926
First Posted: November 24, 2008
Last Update Posted: October 7, 2011
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.
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre
  Purpose
Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes

Condition Intervention Phase
Xerophthalmia Blepharitis Drug: Systane Ultra eyedrops Drug: Refresh eye drops Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Louis Tong, Singapore National Eye Centre:

Primary Outcome Measures:
  • 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:
  • 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

  • Tear Break Up Time (TBUT) [ Time Frame: 6 weeks ]
  • Schirmer I Reading [ Time Frame: 6 weeks ]
  • Meibography Grading [ Time Frame: 6 weeks ]
  • Tear Osmolarity [ Time Frame: 6 weeks ]
    This is measured by the TearLab (Ocusense) system

  • Superior and Inferior Tear Meniscus Height [ Time Frame: 6 weeks ]
    This is determined by anterior segment OCT visante system


Enrollment: 30
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00796926


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

Responsible Party: Louis Tong, Clinician-Scientist, Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT00796926     History of Changes
Other Study ID Numbers: R632/53/2008
First Submitted: November 21, 2008
First Posted: November 24, 2008
Results First Submitted: June 20, 2011
Results First Posted: August 12, 2011
Last Update Posted: October 7, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Blepharitis
Xerophthalmia
Eyelid Diseases
Eye Diseases
Conjunctival Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Laxatives
Gastrointestinal Agents